USFDAJul 8, 2026, 06:07 AM
Amphastar Subsidiary Receives FDA Warning Letter for CGMP Violations
AI Summary
Amphastar Pharmaceuticals announced that its subsidiary, International Medication Systems, Limited (IMS), received a Warning Letter from the FDA on July 2, 2026. The letter cites violations of current Good Manufacturing Practice (CGMP) regulations at IMS's South El Monte, California facility, following a December 2025 inspection. While the letter does not halt production or require a recall, IMS is required to submit a response and remediation plan within 15 working days. The company is evaluating the impact and cannot assure the FDA's satisfaction with its response or the timing of resolution.
Key Highlights
- Amphastar's subsidiary, IMS, received an FDA Warning Letter on July 2, 2026.
- The Warning Letter cites violations of current Good Manufacturing Practice (CGMP) regulations.
- Violations relate to investigation procedures, environmental monitoring, and manufacturing equipment.
- The letter follows an FDA inspection of the South El Monte, California facility in December 2025.
- The Warning Letter does not direct IMS to cease or restrict product manufacturing or require a recall.
- IMS is implementing corrective actions and a remediation plan in response to the letter.
Price Impact
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