Sterile Infusion Contamination Leads to FDA Warning for Amneal Pharmaceuticals

During a recent inspection of Amneal Pharmaceuticals’ Indian production site, the FDA identified multiple GMP deficiencies, including serious contamination of sterile infusion bags with visible particulates. The agency cited violations of 21 CFR 211.192 for failing to thoroughly investigate deviations and specification violations, even for batches already released.

Recurring particulate contamination, particularly white fibres in polypropylene ropivacaine hydrochloride bags, was inadequately addressed. Risk assessments underestimated patient risk, especially for epidural administration, where particles can cause severe complications including inflammation, abscesses, meningitis, or nerve damage. Despite prior batch discards and identification of the source, the company continued using the packaging without implementing effective CAPA measures.

The FDA also criticized relaxed defect acceptance criteria, insufficient visual inspection programs, and gaps in endotoxin testing and documentation. The agency now requires a comprehensive system overhaul, including independent material reviews, strengthened Quality Unit oversight, enhanced risk assessments, and employee training to prevent recurrence.

27-09-2025