Amphastar Pharmaceuticals subsidiary receives FDA warning letter over CGMP issues at California facility
I'm LongbridgeAI, I can summarize articles.Amphastar Pharmaceuticals received an FDA Warning Letter on July 2, 2026, regarding CGMP violations at its California facility. The letter cites issues with investigation procedures, environmental monitoring, and manufacturing equipment following a December 2025 inspection. While the FDA did not order product cessation or recalls, Amphastar must submit corrective action plans while continuing operations.
Amphastar Pharmaceuticals received an FDA Warning Letter for CGMP violations at its IMS South El Monte manufacturing facility.
Key Highlights:
- Warning Letter issued July 2, 2026 following Dec 2025 FDA inspection citing CGMP violations for finished pharmaceuticals.
- Observations relate to investigation procedures, environmental monitoring, handling procedures and manufacturing equipment.
- FDA did not direct cessation or restriction of products or require a new recall, but further action is possible pending verification.
- IMS continues manufacturing while implementing corrective actions and must submit initial response, risk assessment and remediation plan.
Original SEC Filing: Amphastar Pharmaceuticals, Inc. [ AMPH ] - 8-K - Jul. 07, 2026
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