Women's Clothing Boutique Near Me Clayton, NC

The US FDA has raised concerns about manufacturing operations at Novo Nordisk’s API facility in Clayton, North Carolina.

According to a search of the US FDA’s database, agency inspectors issued a Form 483 to Novo Nordisk after visiting the facility – which is assigned the FEI number 1000158576 – on July 13.

A Form 483 is issued to management at the conclusion of an inspection when an investigator has observed any conditions that “in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”

Lars Otto Andersen-Lange, Novo Nordisk’s director of media relations, told us: “Following the FDA’s inspection in July 2023, we have responded to their observations and the site is running and producing for the market.”

Novo Nordisk set up the Clayton facility in 2016, explaining the $1.8 billion, 417,639 square-foot site would produce APIs for a range of its current and future GLP-1 and insulin medicines.

Rybelsus facility

“The facility cited in this letter manufactures API for Rybelsus,” Anderson-Lange told us. Rybelsus (semaglutide) was approved in 2019 by the FDA to improve blood sugar in adults with type 2 diabetes.

Semaglutide is also the active component in the weight-loss drug Wegovy and type 2 diabetes medicine, Ozempic, though – despite media reports – neither Ozempic nor Wegovy is made at Clayton, Anderson-Lange confirmed.

News of the Form 483 follows less than a month after Novo Nordisk revealed that US FDA inspectors had identified problems at a facility operated by Catalent in Brussels where Wegovy injection pens are filled.

According to Reuters, Novo Nordisk has since hired Thermo Fisher as a second contract manufacturer for the drug.

The newswire reported that Thermo is filling the injection pens at its factory in Greenville, North Carolina.

This article was updated on 21 September at 5.13 am.

325 McCullers St, Clayton, NC 27520

Join your Downtown Development Association at Municipal Park this fall for the first ever Clayton BBQ Challenge, presented by Agri Supply! This event features three key components:

Join us in Downtown Clayton from 2pm-6pm for a fun afternoon with three of our communities' favorites things: Bands, Beer, and BBQ!

Ticket Options

There are four different ticket options for this event. All ticket options include entry into the event, beer sampling and an opportunity to hear all bands on stage throughout the day. Tasting the competition BBQ samples or ordering from food trucks is an additional fee for general admission tickets. The DD/Under 21 ticket is provided for those that do not want to sample beer. Looking to be fully immersed in the Clayton BBQ Challenge Experience? Go for the all-inclusive Platinum Pit Experience Ticket!

TICKET PURCHASING

This event has ended.

Parking information

Municipal Park is a short walk from any on-street or public parking lots throughout Downtown Clayton. There will be some on-site parking at Municipal Park and on-street parking on Stallings Street. Overflow public parking options are outlined in the parking category of THIS MAP.

Band, Food Truck and Brewery Line up coming soon!

This event will feature 20+ NC breweries, bands on stage throughout the day and multiple food trucks to satisfy anyone's cravings outside of the delicious BBQ being cooked.

About the Downtown Development Association (DDA)

The Downtown Development Association (DDA) is a 501c3 non-profit dedicated to the improvement of Downtown Clayton. We serve the businesses and community members through the promotion, design, and development of our Downtown area. Fundraising efforts go directly back into community projects that enhance and protect Downtown Clayton. Our goal is to continue to keep our Downtown area a thriving and vibrant community. Your support of the DDA has a huge impact on our community and businesses and we value your contribution.

About the Kansas City Barbeque Society (KCBS)

The Kansas City Barbeque Society (KCBS), a nonprofit organization dedicated to promoting and enjoying barbeque, is the world's largest organization of barbeque and grilling enthusiasts with over 16,000 members worldwide. KCBS sanctions over 300 barbeque contests world wide. From volunteering to actual event production, our members also offer assistance to civic and charitable organizations who organize events.

Please note: this event will be rain or shine and all attendees must be 21+ to consume alcohol.

Many people know it simply as 40/42, the unincorporated community that has sprung up around where N.C. 42 meets Interstate 40 in western Johnston County.

But that name may soon become an anachronism. The N.C. Department of Transportation plans to eliminate nearly 9 miles of N.C. 42 southwest of Clayton, including the section through the Cleveland community where 40/42 is familiar short-hand. Part of what is now N.C. 42, between N.C. 50 and the Clayton Bypass, will be renamed N.C. 36.

The change is necessary, NCDOT officials say, to avoid confusion with Interstate 42, the new name of the highway now known as both U.S. 70 and the Clayton Bypass. I-42 will cross what is now N.C. 42, and both roads will intersect I-40, potentially befuddling visitors and others unfamiliar with the local nomenclature.

That confusion could have serious consequences if someone calling 911 doesn’t know the difference between I-42 and N.C. 42, says Kevin Lacy, NCDOT’s director of strategic planning.

“We’re thinking about how do we keep people from being lost and not being confused when they’re calling for help,” Lacy said in an interview. “Keeping it as simple as we can is our desire in these scenarios.”

NCDOT officials will explain the change and the reasoning behind it at a meeting on Tuesday, July 25, at Clayton Town Hall, from 5 to 7 p.m. The department will also collect questions and feedback online at publicinput.com/US70-NC42-Clayton through Aug. 8.

NCDOT had hoped to avoid changing the name of N.C. 42 by having the planned interstate highway from I-40 to Morehead City called Interstate 36. There isn’t an I-36 anywhere in the nation, and no highway 36 in North Carolina.

But the power to name interstate highways rests with the Federal Highway Administration, based on recommendations from the American Association of State Highway and Transportation Officials or AASHTO. The organization follows a few conventions for interstate highways, including that east-west roads are generally even numbered, while north-south roads are odd. I-36 would have been consistent with that.

Another convention is that interstate numbers get smaller from north to south and east to west (think I-95 along the East Coast, I-10 along the Gulf of Mexico, etc.). Since the new interstate across Eastern North Carolina would be north of I-40, AASHTO chose to name it I-42 instead of I-36.

Last year, the Federal Highway Administration approved the I-42 designation for two sections of the planned highway — the 10-mile bypass around Clayton and the 22-mile Goldsboro bypass in Wayne and Lenoir counties. Those two stretches of U.S. 70 were built to federal interstate standards, while NCDOT is upgrading the rest in stages, until the entire highway from I-40 to Morehead City becomes I-42.

NCDOT hopes to begin erecting I-42 signs in Johnston County within a year. But first it needs to settle on a new name for N.C. 42.

It proposes a new N.C. 36 that runs more than 10 miles. It would begin at N.C. 50 in the west and follow the current N.C. 42 through Cleveland to the bypass. From there it would jog east to Ranch Road and connect back up with N.C. 42 on the southeast side of Clayton.

NCDOT plans to rename only the one stretch of N.C. 42 in Johnston County; the highway will remain N.C. 42 west of Johnston County to Asheboro and east of Clayton to Ahoskie.

Lacy said in addition to N.C. 36, NCDOT would like to see Clayton and Johnston County give N.C. 42 a local name, such as South Lombard Street, so that residents and businesses would have an address that doesn’t rely on an NCDOT number. That approach works well in Wake County, he said, with roads such as Capital Boulevard (U.S. 1) and Glenwood Avenue (U.S. 70).

N.C. 42 and the Clayton Bypass aren’t the only roads that will get new names in Johnston County. With the bypass now known as U.S. 70 becoming an interstate highway, NCDOT also plans to eliminate U.S. 70 Business through Clayton and refer to it again simply as U.S. 70.

Again the goal is simplicity, Lacy said. People won’t have to think about which U.S. 70 they’re on through Clayton. It’s also easier for NCDOT if each highway has just one route number.

“When we can get rid of duplicate names like that, we’ve been trying to do that,” Lacy said. ”It makes signing a little easier. It makes informing the public of alternate routes easier.”

U.S. 70 Business originated in 2008 when the Clayton Bypass opened and became U.S. 70. Shifting it back shouldn’t be that difficult, Lacy said. Homes and businesses along the road through town kept the same address numbers.

Eliminating nearly 9 miles of N.C. 42 will be a bigger adjustment, as addresses are changed to reflect a new route number or a new local name.

There will also be a cultural adjustment.

“The locals that call it 40/42 probably will for a very, very long time, talking to each other,” Lacy said. “They’ll know the new people who are moving in. They’ll be the people who don’t recognize 40/42 as a location name.”

This story was originally published July 21, 2023, 7:00 AM.

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina production plant. The facility produces major drug ingredients like semaglutide, the molecule behind Novo’s oral diabetes drug Rybelsus.

After inspecting Novo’s Clayton facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

Specifically, the two-observation report suggested Novo failed to thoroughly investigate unexplained batch discrepancies and dropped the ball when it comes to microbial controls.

As for what those “discrepancies” were, the FDA said Novo on at least three separate occasions identified “objectionable organisms” during in-process testing of intermediate semaglutide.

Amid high demand, Novo Nordisk temporarily throttles US supply of low-dose Wegovy

In terms of controls, microbial limits “have not been established for in-process API material," in which microbes were discovered during the recovery phase, the FDA went on to say.

In an email to Fierce Pharma, a Novo Nordisk spokesperson said the company doesn’t share details publicly about specific interactions with the FDA, but she noted the Clayton site is “running and producing for the market.”

"The facility cited in this letter manufactures API for Rybelsus, not Ozempic or Wegovy," the spokesperson added.

On the heels of a $2.58-billion global manufacturing investment last December, Novo in March spent $6.8 million to scoop up 104 acres of adjacent land to its Clayton site.

"For Novo Nordisk's production facilities in Johnston County, these land purchases are to ensure North Carolina remains a prime location for future potential expansion plans to improve and increase production capacity," Chad Henry, Novo Nordisk's general manager of U.S. product supply, said at the time.

Novo Nordisk had no current plans to develop the purchased land, the company told Fierce Pharma this past spring.

Novo Nordisk set to launch weight loss drugs in more countries but in constrained fashion, CEO says

Novo Nordisk began operations in Clayton in 1993 with a plant that formulates and fills cartridges and vials, assembles pen devices and packages and labels the products.

After several expansions of the 457,000-square-foot facility, which employs 1,000 people, Novo Nordisk built a $2 billion plant next door that went online in 2021. It employs 700 people and is the company’s first facility outside of Denmark to produce active pharmaceutical ingredients.

Editor's note: This article has been updated to specify that Novo Nordisk's Clayton, NC, facility produces drug ingredients for Rybelsus, not Ozempic and Wegovy.

Fast-growing Clayton is getting a sweet treat in the form of a new bakery with a statewide following.

Burney's Sweets and More is bringing a location to downtown Clayton, according to franchise owner Jaclyn Finn. The bakery will be located at 312 East Main Street, setting up shop in the former space of Nina's Restaurant and Bar, which closed in August.

Finn, a native of the Fayetteville-Raeford area, said she has lived in Clayton for eight years. For the past six years, she and her husband have run a coffee shop, Boulevard West, at 104 West Main Street.

She told Triangle Business Journal they "have been thinking about what we can bring to downtown Clayton that we're missing and locals and visitors could enjoy," and they arrived at a bakery concept.

"Partnering with Burney's was a no-brainer," Finn said. "We've been to multiple locations and absolutely loved it. And we think their products are perfect for the area."

Burney's got its start in 2011 in Elizabethtown in rural Bladen County – located south of Fayetteville. The bakery was founded by Thomas and Doris Burney and today is owned by their son Michael and his wife, Gina.

The business has grown to 15 locations throughout North Carolina – from Charlotte to Southport –including a Raleigh location and one in Smithfield as well. The bakery sells a variety of cakes, pastries, pies and more.

Finn said she is tentatively planning to open the 2,000-square-foot Clayton store in March 2024, and she plans to employ 12 to 15 people. She didn't have estimates for renovation costs and the number of seats the bakery will contain, but said that the store will feature indoor and outdoor seating options.

According to Finn, while she focuses on the bakery, her husband will focus on the coffee shop. She said she may keep the Clayton Burney's location closed on Mondays to give her staff a break and stay open on weekends to attract after-dinner guest. Finn said she is looking into carrying gelato and sorbet, as she is talking with a vendor from Italy.

With roughly 30,000 people, Clayton is one of the fastest-growing towns in North Carolina. As such, it is attracting major residential and industrial projects. Meanwhile, retail is an area that the town is looking to grow, according to Patrick Pierce, economic development director for the Clayton.

Ben Tobin covers real estate and economic development in the Greater Triangle, focusing on the counties outside Wake and Durham. Have a tip? Reach him at btobihn@bizjournals.com or (919) 327-1012.