The U.S. Food and Drug Administration (USFDA) has delivered a strong criticism to Amneal Pharmaceuticals, issuing a warning letter on August 27, 2025, for serious infractions in manufacturing practices at its Gujarat facility. During a March 10-19, 2025 inspection, USFDA investigators documented multiple violations of Current Good Manufacturing Practice (CGMP) regulations, as outlined in Title 21 CFR Parts 210 and 211. These deficiencies render the company’s drug products “adulterated” under the Federal Food, Drug, and Cosmetic Act.
The standout issue involves polymeric intravenous (IV) bags that were found to shed visible white fiber particulates into ropivacaine hydrochloride injection preparations. Despite recognizing the dangers, particularly given the medication’s epidural route, the company’s investigation was deemed inadequate. The risk assessment notably downplayed severe patient safety risks, including possible inflammation, epidural abscess, meningitis, spinal cord damage, or permanent nerve injury.
Alarmingly, these polypropylene bags had been identified as a contamination source as early as late 2022 and early 2023. Yet Amneal continued to use them and even relaxed the rejection thresholds to allow increased use of the flawed components, an approach the USFDA found unacceptable.
Amneal initiated a Field Alert Report on March 26, 2025, and recalled the affected lots of ropivacaine hydrochloride on April 18—but notably, these steps were taken only after USFDA raised concerns during inspection. Industry observers have called out the company for its delayed corrective actions.
In response to media scrutiny, an Amneal spokesperson stated that the warning letter did not require a halt in manufacturing or marketing of its approved products, attempting to frame the letter as a contained issue.
According to the USFDA, under the Generic Drug User Fee Amendments (GDUFA III) for fiscal years 2023–2027, Amneal’s facility may be eligible to request a Post-Warning Letter Meeting to discuss its corrective action strategy . The USFDA likely expects transparent, effective corrective and preventive actions (CAPA), especially in light of the repeated contamination concerns.
