Form 8-K Amphastar Pharmaceutical For: Jul 02

Go back to Form 8-K Amphastar Pharmaceutical For: Jul 02

FDA issues warning letter to Amphastar Pharma subsidiary over manufacturing

July 8, 2026 6:04 AM EDT

Amphastar Pharmaceuticals (NASDAQ: AMPH) disclosed that its subsidiary, International Medication Systems, Limited (IMS), received a warning letter from the U.S. Food and Drug Administration on July 2, 2026, related to its drug manufacturing facility in South El Monte, California.

The warning letter follows an FDA inspection of the facility conducted in December 2025,... More