The FDA issued a warning letter to Amneal Pharmaceuticals criticizing the drugmaker for failing to correct problems that led to a string of recalls of its generic vancomycin and ropivacaine hydrochloride products.
Manufacturing issues have been an ongoing problem for Amneal for more than two years.
The warning letter, which was issued Aug. 27 and posted to the regulatory agency’s website, cited the company for not thoroughly investigating unexplained discrepancies and failures related to the manufacture and packaging of the product. The regulator also scolded Amneal for failing to establish proper laboratory controls.
The regulatory rebuke follows a March 10-19 inspection of Amneal’s production facility in Gujarat, India.
“Your firm was aware of the risk of particulate contamination from the polypropylene bags purchased from your vendor for more than a year prior to your 2024 investigation,” the FDA said. “You had rejected several batches of a sterile drug product after investigating particulate contamination in late 2022 and early 2023.
“However, you continued to use these polypropylene bags to produce sterile injectable drug products and did not implement appropriate corrective action and preventive action (CAPA) to prevent recurrence.”
The agency further chastised the company for minimizing the severity of risks associated with particle contamination in its health hazard assessment as part of its previous responses to the FDA.
In particular, the company’s quality unit “is not fully exercising its authority,” the agency said.
In March 2024, Amneal issued a voluntary recall of four lots of ropivacaine after it found two batches packaged in polypropylene bags were overfilled, which could lead to dosing that exceeds the recommended maximum daily allowance. The limit is set at up to 2 mg per day, but the packaging mistake could have caused patients to receive double that dose.
In April of this year, the company recalled two lots of ropivacaine after inert “fibers” were found to have leeched into the IV bags. Then in June, Amneal issued a recall for three lots of sulfamethoxazole/trimethoprim tablets after a customer reported microbial contamination that caused black spots to appear.