FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Following an enforcement lull over the past few weeks, the U.S. FDA has unleashed a salvo of pharmaceutical warning letters targeting both manufacturing infractions and online sales of knockoff weight loss meds.

On the production front, the FDA chided Indian ophthalmology player Madhu Instruments in a letter dated Feb. 1. The FDA laid out its concerns after inspecting Madhu Instruments’ manufacturing facility in New Delhi from Oct. 11-21, 2022, which yielded a Form 483.

The FDA also placed Madhu Instruments on import alert on May 31, 2023. While the company offered a response to the FDA’s Form 483 back in November 2022, its response was subpar, according to the FDA.

Ultimately, the FDA determined that certain products manufactured at Madhu Instruments' plant are adulterated because they’ve either been prepared, packed or held under insanitary conditions. In turn, those products could be “contaminated with filth” or “rendered injurious to health,” the FDA added.

The regulator’s hygiene concerns didn’t stop there, either, with investigators slamming the ophthalmology outfit over the cleanliness of its plant writ large.

Specifically, the FDA investigators noted Madhu Instruments’ facility was in a “state of disrepair.”

Agency officials found peeling paint on the ceilings of manufacturing rooms as well as a plastic bag covering a HEPA filter in the manufacturing area, which impeded airflow. Further, investigators found broken tiles along the base of the wall in the manufacturing rooms that had “residue adhering to them.”

In turn, Madhu Instruments’ plant isn’t suitable for drug and device production, the FDA explained. The regulator also pointed to “visibly dirty” and “stained” manufacturing equipment.

Formed in 1989, Madhu Instruments says on its website that it aims to become the “undisputed leader” in its segments of the ophthalmic industry.

“Our commitment towards quality is paramount and we believe good healthcare is a right of every human being, which is why manufacturing devices that are 100% reliable through constant progressive innovation is not only our passion but a commitment towards our vision,” Madhu Instruments says online.

Also in February, the FDA dispensed warning letters to Miami’s US Chem Labs and New York City’s Synthetix. Both companies were accused of peddling unapproved versions of Novo Nordisk and Eli Lilly’s respective obesity and diabetes meds, semaglutide and tirzepatide.

Novo’s semaglutide is sold as Ozempic and Rybelsus in Type 2 diabetes and bears the name Wegovy in obesity. Lilly’s tirzepatide, for its part, is called Mounjaro in diabetes and Zepbound for weight loss.

According to the FDA, both US Chem and Synthetix listed illicit GLP-1s on their websites as “research chemicals only” and “not for human consumption” despite evidence to the contrary.

What’s more, US Chem also markets the peptide thymalin, claiming it can boost patients' immune systems and metabolisms. In its warning letter, the FDA said it was “particularly concerned” that the company was marketing this drug for use in children.

Aside from being unapproved versions of established and marketed drugs, US Chem's and Synthetix’s versions of semaglutide and tirzepatide are considered misbranded because the companies failed to include labeling with proper instructions for use, the FDA said.

With the FDA’s help, both Eli Lilly and Novo Nordisk have been going after counterfeit versions of their meds in recent months. The phenomenon of a GLP-1 black market is likely related to, at least in part, high demand and persistent shortages of both companies’ drugs.

Last week, meanwhile, Novo Nordisk reached confidential settlements with two Florida peddlers of compounded semaglutide. The settlement includes permanent injunction orders, which call on the sellers to stop using Novo trademarks and disclose for a year that compounded versions of Ozempic and Wegovy haven’t gone through the safety and efficacy standards the FDA requires for approved medications.

It's been a busy year so far for the FDA, which dispensed multiple warning letters in January. Late last month, Mexico’s Glicerinas Industriales, which supplies drug components like glycerin to pharmaceutical manufacturers, was nailed with a warning letter citing the company for product testing and documentation shortfalls.