It's no secret, most of us would like to stay in our own home as we age. Yet, sometimes our loved ones just need a little extra help to remain comfortable at home. That's where Always Best Care can help....we are dedicated to exceeding expectations....always
They say that your golden years are the best years of your life. For most older Americans, that's how it should be - a time to relax, reflect, and live life in a familiar place. After all, senior citizens in the U.S. have worked tirelessly to build a better economy, serve their communities, and raise families.
Unfortunately, many older Americans aren't able to rely on their adult children for help. The reality in today's world is that family members do not have the skills or time to dedicate to caring for their parents. That's where Always Best Care Senior Services comes in.
Our in-home care services are for people who prefer to stay at home as they grow older but need ongoing care that family or friends cannot provide. More and more older adults prefer to live far away from long-term, institutionalized facilities and closer to the place where they feel most comfortable - their home. Home care in Greenville, NC is a safe, effective way to give your loved ones the care they need when they need it the most.
Home Care Services
Service AreasSince 1996, Always Best Care has provided non-medical in-home care for seniors to help them maintain a healthy lifestyle as they get older. We are proud to have helped more than 25,000 seniors maintain higher levels of dignity and respect. We focus on providing seniors with the highest level of in-home care available so that they may live happily and independently.
Unlike some senior care companies, we genuinely want to be included in our clients' lives. We believe that personalized care is always the better option over a "one size fits all" approach. To make sure our senior clients receive the best care possible, we pair them with compassionate caregivers who understand their unique needs. That way, they may provide care accordingly without compromising their wellbeing.
The Always Best Care difference lies in life's little moments - where compassionate care and trustworthy experience come together to help seniors live a fruitful, healthy life. Whether you are an aging adult that can't quite keep up with life's daily tasks or the child of a senior who needs regular in-home services, Always Best Care is here to help.
“Such a wonderful place to work! Caregivers that genuinely care with office support that go”
“I bn with this company for Abt a year and I love working for them”
“I cannot say enough good things about this company and the caregivers they provided after”
“This company is TOP-NOTCH! Incredibly helpful and super friendly. If you’re looking for a part-time”
“Sandy is very knowledgeable of assisted living options in the Winston Salem area. She helped”
“I highly recommend Sandy Bowen with Always Best Care. I called her with a very”
“The staff and caretakers are wonderful. Would absolutely recommend to anyone who needs at home”
“These folks are so helpful! They care about their clients and it shows in the”
“The staff and caretakers are wonderful. Would absolutely recommend to anyone who needs at home”
“During an unexpected hospital stay, Joanne provided much needed assistance. She provided excellent care and”
“If you are looking for attentive, quality home care look no further than Joanne and”
“Such a wonderful place to work! Caregivers that genuinely care with office support that go above and beyond for staff/clients. Highly recommend for employment and senior in-home care support.”
“I bn with this company for Abt a year and I love working for them . They work with you,they care about ur personal life/ problems, really good at matching you with good clients..”
“I cannot say enough good things about this company and the caregivers they provided after my mom's recent accident and stay in a rehab facility. The staff were constantly in communication with us keeping us abreast of any little or big updates. Their attitudes were always helpful and they seemed to genuinely care. The caregivers they sent to sit with and take care of mom were EXCELLENT. I'm not sure how many different caregivers she had over the few weeks of her stay but there wasn't a single one that wasn't kind and extremely helpful. It took a tremendous load off of everyone in our family knowing that she was being well cared for when we couldn't be there. Thank you to Brandi, Joanne, Gina, and anyone I'm missing for everything you all did for us from the beginning of the process all the way to my mom's release today. Hopefully, we won't need your services again, but if we do, I know who I will be calling!”
“This company is TOP-NOTCH! Incredibly helpful and super friendly. If you’re looking for a part-time in caregiving, this is it! ⭐️⭐️⭐️⭐️⭐️”
“Sandy is very knowledgeable of assisted living options in the Winston Salem area. She helped with a family member’s search with care and consideration. We highly recommend.”
“I highly recommend Sandy Bowen with Always Best Care. I called her with a very tight timeframe to find a suitable memory care facility for my family member. She asked a lot of questions about my loved one to try and get to know her as much as possible. She worked very fast and lined up several appointments for us to tour places within a matter of days. She explained the process to me every step of the way and made sure we stayed on track. She attended the appointments with me and asked questions that I would never think to ask. I can’t thank her enough.”
“The staff and caretakers are wonderful. Would absolutely recommend to anyone who needs at home care for themselves or loved ones”
“These folks are so helpful! They care about their clients and it shows in the service! I highly recommend ????”
“The staff and caretakers are wonderful. Would absolutely recommend to anyone who needs at home care for themselves or loved ones”
“During an unexpected hospital stay, Joanne provided much needed assistance. She provided excellent care and supportive advocacy. It made dealing with the discomfort more bearable and gave me a safeguard to decipher the complicated choices to resolve health issues. I highly recommend this service.”
“If you are looking for attentive, quality home care look no further than Joanne and her team. A passion for excellence is driven for from this team. Family oriented and willing to work with all families.”
Home is where the heart is. While that saying can sound a tad cliche, it is especially true for many seniors living in America. When given a choice, older adults most often prefer to grow older at home. An AARP study found that three out of four adults over the age of 50 want to stay in their homes and communities as they age.
When you begin to think about why, it makes sense. Home offers a sense of security, comfort, and familiarity.
The truth is, as we age, we begin to rely on others for help. When a family is too busy or lives too far away to fulfill this role, in-home senior care is often the best solution. Home care services allow seniors to enjoy personal independence while also receiving trustworthy assistance from a trained caregiver.
At Always Best Care, we offer a comprehensive range of home care services to help seniors stay healthy while they get the help they need to remain independent. As your senior loved one gets older, giving them the gift of senior care is one of the best ways to show your love, even if you live far away.
To give our senior clients the best care possible, we offer a full spectrum of in-home care services:
If your senior loved one has specific care needs, our personal care services are a great choice to consider. Personal care includes the standard caregiving duties associated with companion care and includes help with tasks such as dressing and grooming. Personal care can also help individuals with chronic conditions like diabetes.
Common personal care services include assistance with:
Sometimes, seniors need helpful reminders to maintain a high quality of life at home. If you or your senior has trouble with everyday tasks like cooking, our home helper services will be very beneficial.
Common home helper care services include assistance with:
Using this kind of care is a fantastic way to make life easier for you or your senior loved one. At Always Best Care, our talented caregivers often fill the role of a companion for seniors.
Common companionship services include:
According to AARP, more than 53 million adults living in the U.S. provide care to someone over 50 years old. Unfortunately, these caregivers experience stress, exhaustion, and even depression. Our respite care services help family caregivers address urgent obligations, spend time with their children, and enjoy nearby activities. Perhaps more importantly, respite care gives family members time to recharge and regroup. Taking personal time to de-stress reduces the risk of caregiver burnout. Doing so is great for both you and your loved one.
At the end of the day, our goal is to become a valuable part of your senior's daily routine. That way, we may help give them the highest quality of life possible. We know that staying at home is important for your loved one, and we are here to help make sure that is possible.
If you have been on the fence about non-medical home care, there has never been a better time than now to give your senior the care, assistance, and companionship they deserve.
Always Best Care in-home services are for older adults who prefer to stay at home but need ongoing care that friends and family cannot provide. In-home care is a safe, effective way for seniors to age gracefully in a familiar place and live independent, non-institutionalized lives. The benefits of non-medical home care are numerous. Here are just a few reasons to consider senior care services from Always Best Care:
According to AARP, 9 out of 10 seniors prefer to age in place within the comfort of their own home. With in-home care, seniors have a way to stay at home, receive the care they need, and maintain a sense of independence, improving overall wellness.
If you or a member of your family have assumed the role of caregiver for your senior loved one, you know how stressful the job can be. Between caregiver burnout and constant worry, being a family caregiver is hard. In-home care relieves your burden and gives you peace of mind knowing that your older family member is in expert hands.
Unlike nursing homes, where the staff and residents rotate frequently, seniors can foster new friendships and build bonds with their caregiver. Seniors who socialize on a regular basis are often happier, which fosters positivity and leads to increased wellbeing.
No two seniors need the same kind of in-home care assistance. That is why each of our Care Plans is tailored to meet our client's individual needs. We offer plans that cover everything from light housekeeping to more involved duties like transportation to doctor's appointments. Our Care Coordinators will work closely with you to develop a personalized plan to ensure your senior's needs are exceeded.
Always Best Care offers a full array of care options for patients at all levels of health. With our trusted elderly care services, your loved one will receive the level of care necessary for them to enjoy the highest possible quality of life.
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While it's true that some seniors have complicated medical needs that prevent them from staying at home, aging in place is often the best arrangement for seniors and their families. With a trusted caregiver, seniors have the opportunity to live with a sense of dignity and do so as they see fit - something that is unavailable to many older people today.
In-home care makes it possible for millions of seniors to age in place every year. Rather than moving to a strange nursing home, seniors have the chance to stay at home where they feel the happiest and most comfortable.
How much does a senior's home truly mean to them?
A study published by the American Society on Aging found that more than half of seniors say their home's emotional value means more than how much their home is worth in monetary value. It stands to reason, then, that a senior's home is where they want to grow old.
With the help of elderly care in Greenville, NC, seniors don't have to age in a sterilized care facility. Instead, they can age gracefully in the place they want to be most: their home. In contrast, seniors who move to a long-term care facility must adapt to new environments, new people, and new systems that the facility implements. At this stage in life, this kind of drastic change can be more harmful than helpful.
Institutional care facilities like nursing homes often put large groups of people together to live in one location. On any given day, dozens of staff members and caregivers run in and out of these facilities. Being around so many new people in a relatively small living environment can be dangerous for a seniors' health and wellbeing. When you consider that thousands of seniors passed away in nursing homes during the COVID-19 pandemic, opting for in-home care is often a safer, healthier choice for seniors.
Aging in place has been shown to improve seniors' quality of life, which helps boost physical health and also helps insulate them from viral and bacterial risks found in elderly living facilities.
For many seniors, the ability to live independently with assistance from a caregiver is a priceless option. With in-home care, seniors experience a higher level of independence and freedom - much more so than in other settings like a nursing home. When a senior has the chance to age in place, they get to live life on their own terms, inside the house that they helped make into a home. More independence means more control over their personal lives, too, which leads to increased levels of fulfillment, happiness, and personal gratification. Over time, these positive feelings can manifest into a healthier, longer life.
More independence, a healthier life, and increased comfort are only a few benefits of aging in place. You have to take into consideration the role of cost and convenience. Simply put, it's usually easier and more affordable to help seniors age in place than it is to move them into an institutional care facility. According to the US Department of Housing and Urban Development, seniors who age in the comfort of their homes can save thousands of dollars per month.
In-home care services from Always Best Care, for instance, are often less expensive than long-term solutions, which can cost upwards of six figures per year. To make matters worse, many residential care facilities are reluctant to accept long-term care insurance and other types of payment assistance.
With Always Best Care's home care services, seniors and their families have a greater level of control over their care plans. In-home care gives seniors the chance to form a bond with a trusted caregiver and also receive unmatched care that is catered to their needs. In long-term care facilities, seniors and their loved ones have much less control over their care plan and have less of a say in who provides their care.
In-home care is a valuable resource that empowers seniors to age in place on their own terms. However, a big concern for many families and their loved ones is how much in-home care costs. If you're worried that in-home care is too expensive, you may be pleasantly surprised to learn that it is one of the most affordable senior care arrangements available.
Typically, hiring an Always Best Care in-home caregiver for a few hours a week is more affordable than sending your loved one to a long-term care facility. This is true even for seniors with more complex care needs.
At Always Best Care, we will work closely with you and your family to develop a Care Plan that not only meets your care needs, but your budget requirements, too. Once we discover the level of care that you or your senior need, we develop an in-home care plan that you can afford.
In addition to our flexible care options, families should also consider the following resources to help offset potential home care costs:
When you or your senior loved one needs assistance managing daily tasks at home, finding a qualified caregiver can be challenging. It takes a special kind of person to provide reliable care for your senior loved one. However, a caregiver's role involves more than meal preparation and medication reminders. Many seniors rely on their caregivers for companionship, too.
Our companion care services give seniors the chance to socialize in a safe environment and engage in activities at home. These important efforts boost morale and provide much-needed relief from repetitive daily routines. A one-on-one, engaging conversation can sharpen seniors' minds and give them something in which to be excited.
At Always Best Care, we only hire care providers that we would trust to care for our own loved ones. Our senior caregivers in Greenville, NC understand how important it is to listen and communicate with their seniors. A seemingly small interaction, like a short hug goodbye, can make a major difference in a senior's day. Instead of battling against feelings of isolation, seniors begin to look forward to seeing their caregiver each week.
Understanding the nuances of senior care is just one of the reasons why our care providers are so great at their job.
Unlike some senior care companies, our caregivers must undergo extensive training before they work for Always Best Care. In addition, our caregivers receive ongoing training throughout the year. This training ensures that their standard of care matches up to the high standards we've come to expect. During this training, they will brush up on their communication skills, safety awareness, and symptom spotting. That way, your loved one receives the highest level of non-medical home care from day one.
While it's true that many seniors prefer to age at home, sometimes in-home care isn't the best fit. For those seniors and their families, choosing an assisted living facility makes more sense. Unfortunately, finding the optimal care facility is easier said than done in today's day and age. That's when Always Best Care's assisted living referral services begin to make a lot of sense.
Assisted living is a form of housing intended for seniors who require varying degrees of medical and personal attention. Accommodations may include single rooms, apartments, or shared living arrangements. Assisted living communities are typically designed to resemble a home-like environment and are physically constructed to encourage the independence of residents.
At assisted living communities, seniors receive help with daily activities such as bathing, dressing, and eating. They may also benefit from coordination of services with outside healthcare providers, and monitoring of resident activities to ensure their health, safety, and well-being. Caregivers who work at assisted living communities can also provide medication administration and personal care services for older adults.
Other services offered within assisted living communities can include some or all of the following:
At Always Best Care, our representatives can match your senior's emotional, physical, and financial needs with viable assisted living communities nearby. Results are based on comparative data, so you can select the best choice for you or your loved one.
Always Best Care works closely with local senior living communities to gain valuable knowledge that we then use to help seniors and their loved ones make informed decisions. This information can include basic care and rent, resident availability, and services provided. Because Always Best Care is compensated by these communities, we provide senior living referral services at no extra cost to you.
For many seniors, moving into a senior living community revolves around how and when they want to make a transition to more involved care. Some seniors are more proactive about transitioning to independent living. Others choose to remain home until their care needs or other requirements are satisfied. Remember - our staff is here to help. Contact our office today to learn more about assisted living communities and how we can find a facility that exceeds your expectations.
The first step in getting quality in-home care starts with a personal consultation with an experienced Always Best Care Care Coordinator. This initial consultation is crucial for our team to learn more about you or your elderly loved one to discover the level of care required. Topics of this consultation typically include:
A discussion of your needs and how our trained caregivers can offer assistance in the most effective way
A draft of your care plan, which includes highly detailed notes and a framework for the care that you or your senior will receive
Discuss payment options and help coordinate billing with your insurance provider
Our caregivers are trained to spot changes that clients exhibit, like mental and physical decline. As your trusted senior care company, we will constantly assess and update your Care Plan to meet any new emotional, intellectual, physical, and emotional needs.
If you have never considered in-home care before, we understand that you and your family may have concerns about your Care Plan and its Care Coordinator. To help give you peace of mind, know that every team member and caregiver must undergo comprehensive training before being assigned to a Care Plan.
At the end of the day, we only hire the best of the best at Always Best Care. Whether you need home care in Greenville, NC 24-hours a day or only need a respite for a couple of hours, we are here to serve you.
When you're ready, we encourage you to contact your local Always Best Care representative to set up a Care Consultation. Our Care Coordinators would be happy to meet with you in person to get to know you better, discuss your needs, and help put together a personalized Care Plan specific to your needs.
From sushi to steak and classic barbecue, Greenville, North Carolina, is packed with a range of restaurants to please every palate. Eastern North Carolina is famous for its barbecue, with some of the best barbecue restaurants in the state. But don’t miss out on these other unique restaurants in Greenville, NC — have you ever tried a Dominican asopao or eaten pork sch...
From sushi to steak and classic barbecue, Greenville, North Carolina, is packed with a range of restaurants to please every palate. Eastern North Carolina is famous for its barbecue, with some of the best barbecue restaurants in the state. But don’t miss out on these other unique restaurants in Greenville, NC — have you ever tried a Dominican asopao or eaten pork schnitzel in an Old English-inspired pub? Read on for some of the best restaurants in Greenville, NC!
If you’re looking for steakhouses in Greenville, NC, look no further than The Seahorse Steakhouse. Known for “Daddy’s steaks and Mama’s cakes,” The Seahorse Steakhouse offers a menu packed with hearty country fare. With daily and nightly specials, the Seahorse is one of the best restaurants in Greenville, NC, for steak as well as seafood. Make sure to save room for some of the best dessert around; with over a dozen different house-made cakes baked daily, from butter pecan to German chocolate, “Mama’s cakes” are half of what makes The Seahorse Steakhouse stand out in the Greenville, NC, dining scene.
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With no menu, no website and no phone number, B’s Barbecue has earned a reputation as one of the best restaurants in Greenville, NC, through sheer word of mouth. The small brick building presents an unassuming front that contains some of the best pulled pork barbecue in eastern North Carolina. The barbecue is served with coleslaw, boiled potatoes and green beans — a deceptively simple menu with a rich flavor. Hot pepper vinegar adorns each table and the picnic tables outside are frequently packed with visitors. B’s shuts down when they run out of food, so it’s advised to get their early to enjoy one of the best restaurants in Greenville, NC.
For a taste of authentic Italian cuisine in the heart of North Carolina, try Nino’s Cucina Italiana. Nino’s brings three generations of Italian cooking to the Greenville, NC, dining scene. As one of the more upscale restaurants in Greenville, Nino’s offers an elegant atmosphere with Italian-inspired decor and a range of imported wines. This family-owned eatery makes its own pasta in house. From savory mushroom ravioli to classic spaghetti, there’s a pasta for every palate, along with fresh seafood, chicken and pork chop dishes. Finish up dinner with taste of tiramisu or cannoli. For a special celebration or just a well-deserved night out, Nino’s is one of the best restaurants in Greenville, NC.
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Sushi, hibachi, tempura and more can all be found on the menu at Shogun in Greenville, NC. One of the best Japanese restaurants in Greenville, Shogun has plenty of vegetarian offerings along with a wide range of sushi. If you’re dining with friends, try a “love boat” sampler of different nigiri sushi and sashimi offerings. Mix and match different hibachi or tempura, try a bento box dinner or a comforting soup with udon or soba noodles. For lunch or dinner, Shogun Japanese Restaurant is one of the best places to eat in Greenville, NC.
If you have a craving for mango lassi, chicken tikka or vegetable samosas, check out one of the best Indian restaurants in Greenville, NC. Kasturi Indian Cuisine offers all of this and more in an elegant setting. Their lunch buffet is open every day of the week until 2:30 p.m., and the restaurant reopens for dinner at 5 p.m. Even if you’re not staying for lunch or dinner, Kasturi has a bar with beer on draft and a selection of wines — as well as free WiFi in case you’re taking a working lunch. End your meal with a hot tea or coffee and rice pudding or Indian ice cream at this elegant Greenville, NC, restaurant.
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If you’re looking for fun, casual eats and drinks in Greenville, NC, Sup Dogs is your ticket. Sup Dogs serves classic and specialty hot dogs in a casual, college-town atmosphere. Sup Dogs ranked 15th in Business Insider’s roundup of the best hot dogs in America and has been named a Best Sports Bar by Barstool Sports three times. In addition to hot dogs, you’ll find a menu packed with nachos, burgers, wings and fries. With rooftop seating and plenty of beer on tap, Sup Dogs is one of the best restaurants in Greenville, NC, for watching local college football.
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Christy’s Euro Pub adds a unique flavor to the Greenville, NC, dining scene. Inspired by the pubs of Old England, Christy’s invites visitors to “grab a bite and a pint.” Christy’s is the perfect setting to gather and relax after work or meet for brunch with friends. Brunch is offered on weekends as well as weekdays, featuring an array of breakfast sandwiches, burgers and burritos. Christy’s standard fare consists of classic pub food with Southern and European influences, from pork schnitzel to buttermilk fried chicken. On nights featuring live music, the pub comes alive with the sound of local bands and open mic performances, held several nights each month.
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Parker’s BBQ is widely known as one of the best Greenville, NC, restaurants for barbecue. For decades, Parker’s has been a staple of Greenville, NC, dining, and their whole-hog barbecue recipe hasn’t changed in 40 years. Their “Parker’s Boxes” are packed with coleslaw, corn sticks, hushpuppies and vegetable sides. With three locations across Greenville, you’re never far from a Parker’s. This family-owned, down-home establishment is one of the best places to eat in Greenville, NC, for an authentic Southern barbecue experience.
For one of the most unique places to eat in Greenville, NC, check out Starlight Café and Farm. True to its name, the restaurant offers a seasonal menu stocked with meat and produce from the nearby Starlight Farm and Gardens. This casual downtown Greenville eatery, which is open for dinner only, offers locally sourced seafood, steaks and cocktails as part of its ever-changing menu. With free parking across downtown Greenville, it’s easier than ever to enjoy a night on the town.
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This popular Greenville, NC, restaurant serves authentic Dominican and Caribbean food in the heart of the South. Enjoy fried calamari on the patio, or try a Dominican asopao, a gumbo-style stew with meat, seafood or vegetables. Villa Verde also offers a number of vegetarian options.
Villa Verde also operates Bella Green Latin Sports Bar & Grill, which hosts Latin Night on Fridays and Saturdays, featuring live music and cocktails with plenty of delicious Latin-inspired dishes to fuel a night of dancing.
GREENVILLE, N.C. (WTVD) -- Vice President Kamala Harris returns to North Carolina for a second weekend in a row.She arrived in Raleigh just before 6:00 p.m. VP Harris helped pack diapers into boxes of personal care products destined for North Carolina hurricane victims, agreeing with one helper who said "It takes a village.&q...
GREENVILLE, N.C. (WTVD) -- Vice President Kamala Harris returns to North Carolina for a second weekend in a row.
She arrived in Raleigh just before 6:00 p.m. VP Harris helped pack diapers into boxes of personal care products destined for North Carolina hurricane victims, agreeing with one helper who said "It takes a village."
"You're exactly right," Harris said as she put two packages of diapers in each cardboard box that was placed in front of her assembly-line style. Harris met with Black leaders at The Pit Authentic Barbecue restaurant in Raleigh before she joined volunteers who were there to pack bandages, baby formula, baby wipes, pain relief pills and other items for victims of Hurricane Helene, which tore through western North Carolina last month.
It takes a village.Vice President Kamala Harris
On Sunday, VP Harris is scheduled to make remarks at a church in Greenville and speak at a campaign rally in the afternoon.
This is the vice president's 19th visit to the Tar Heel state this election cycle.
Harris previously visited the state in the aftermath of Hurricane Helene. After arriving in WNC, she was briefed by state and local officials on the impact of Helene and recovery efforts. She reassured them federal assistance would continue to flow in. She praised local communities for helping each other as the long road to recovery continues.
Saturday, VP Harris' doctor released a summary of her medical history. Vice President Kamala Harris is in "excellent health" and "possesses the physical and mental resiliency" required to serve as president, her doctor said in a letter released Saturday that summarizes her medical history and status.
Dr. Joshua Simmons, a U.S. Army colonel and physician to the vice president, wrote that Harris, 59, maintains a healthy, active lifestyle and that her most recent physical last April was "unremarkable."
She "possesses the physical and mental resiliency required to successfully execute the duties of the Presidency, to include those as Chief Executive, Head of State and Commander in Chief," he wrote in a two-page letter.
WATCH | VP Kamala Harris visits NC to survey storm damage
Harris made stops in the western part of the state last weekend to survey damage from Helene.
The visit was a day after Republican presidential nominee and former President Donald Trump said the federal response to the disaster has been "lousy."
There's a little over three weeks until Election Day, Nov. 5.
Thermo Fisher Scientific is responsible for helping to produce some of the hottest drugs on the market, including Novo Nordisk’s obesity blockbuster Wegovy and Sanofi and AstraZeneca’s infant respiratory syncytial virus (RSV) antibody Beyfortus. But according to the FDA, problems were stacking up at the company’s Greenville, North Carolina, plant earlier this year.The agency inspected the company’s site, which belongs to its Patheon CDMO subsidiary, in May. The 1.5 million-square-foot ...
Thermo Fisher Scientific is responsible for helping to produce some of the hottest drugs on the market, including Novo Nordisk’s obesity blockbuster Wegovy and Sanofi and AstraZeneca’s infant respiratory syncytial virus (RSV) antibody Beyfortus. But according to the FDA, problems were stacking up at the company’s Greenville, North Carolina, plant earlier this year.
The agency inspected the company’s site, which belongs to its Patheon CDMO subsidiary, in May. The 1.5 million-square-foot plant offers sterile dose manufacturing and filling, among other capabilities, and boasts more than 1,500 employees.
According to Reuters, the inspection was part of a larger, now-resolved Thermo Fisher audit relating to the manufacturing of Beyfortus.
"As the commercial lead for Beyfortus, we emphasize that all findings were addressed, reviewed by the regulator, and Beyfortus doses were approved by the FDA prior to being released," Sanofi told Fierce Pharma in an emailed statement. "As always, the safety and quality of our products remains our highest priority."
Sanofi expects RSV antibody to ?breach blockbuster status in 2024, even as supply hitch drags on
During the agency's visit, the FDA identified several issues across multiple areas. For one, the facility had problems with some of its production procedures, one of which relates to monitoring and measuring air bubbles inside syringes, according to FDA documents reviewed by Fierce Pharma.
“Your sampling plan for bubble size do not result in statistical confidence in your process performance,” the inspectors wrote in their report.
Furthermore, according to the report, some visual inspection processes weren’t up to par and used a timeframe not backed by studies, particularly in terms of ensuring that finished product is cleared of particulate matter.
Then, there were concerns with microbiological contamination of sterile drug products. Aspects of the products, including the stoppers, reportedly were not sterilized prior to assembly and in one instance made direct contact with a non-sterile glove. The FDA pointed out that since July 2022, the North Carolina plant had made approximately 35 glove integrity testing failures during filling operations, with six of them impacting undisclosed products. All but one batch of said product was released for commercial distribution, according to the document.
According to the agency, a lack of conclusions and follow-ups—which can include product impact assessments—in written records of investigations mean that in one case, there was no assurance that syringes with certain air bubble sizes were removed from commercial batches during the manufacturing process. There were also reportedly some deviations the company investigated but the definitive root causes of which weren’t identified.
Novo Nordisk tapped Thermo Fisher to help make obesity drug Wegovy amid Catalent woes: Reuters
Finally, the FDA found some red flags in the quality control unit relating to electronic data systems and metadata associated with batch records.
Beyfortus' launch was hampered by supply issues last year, prompting an amped-up manufacturing effort for the upcoming RSV season that includes a new filling line.
Thermo Fisher’s Greenville site also fills Wegovy injection pens after Novo tapped the manufacturer to help overcome its own shortage problems tied to FDA concerns at a Catalent plant.
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