FDA slams Amneal for ‘significant violations’ in warning letter

The FDA has issued a warning letter to Amneal Pharmaceuticals, citing “significant violations” of manufacturing standards after finding the drugmaker used contaminated IV bags in the manufacture of injectable products. 

The violations, discovered during a March inspection of the company’s Gujarat, India, facility, revealed that Amneal continued to manufacture and release drug products, including epidural ropivacaine hydrochloride injections, using polypropylene IV bags known to shed white fibers, according to the FDA’s Aug. 27 letter. 

The fibers pose a serious health risk, particularly for patients receiving epidural injections. Potential outcomes include inflammation, abscesses, meningitis or permanent spinal cord damage. 

Despite being aware of the contamination issue since 2022, Amneal did not implement adequate corrective and preventative actions, the letter said. Instead, the FDA claimed the company relaxed quality standards to accommodate use of defective bags. 

The company recalled two lots of ropivacaine hydrochloride injections in April 2025, but only after the agency identified the issue during its inspection, the letter added. 

The FDA also cited failures in laboratory controls, such as improper bacterial endotoxin testing methods and documentation issues. As a result, the agency ordered Amneal to conduct a sweeping review of its manufacturing, laboratory and quality assurance systems.  

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