Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistAmneal Pharmaceuticals' Indian manufacturing facility failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutical drugs, resulting in adulterated products. The FDA inspection in March 2025 identified critical violations including the company's failure to adequately investigate recurring batches of ropivacaine hydrochloride injection that exceeded visual inspection standards for particulate matter contamination from polypropylene bags, and an inadequate risk assessment that improperly justified releasing contaminated batches to market. The firm's inability to thoroughly investigate batch discrepancies and implement proper contamination controls violated 21 CFR 211.192 and demonstrated systemic deficiencies in manufacturing controls and quality assurance.