Amphastar subsidiary IMS receives FDA warning letter for CGMP violations at South El Monte facility

Amphastar Pharmaceuticals, Inc.

Warning letter dated July 2, 2026, follows December 2025 FDA inspection of IMS's South El Monte, CA facility.
Cites violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
FDA does not direct IMS to cease or restrict products from the facility; no further recall required at this time.
IMS must submit initial response within 15 working days and provide a risk assessment and remediation plan.
Company is evaluating impact; additional regulatory or legal action possible if deficiencies are not resolved.

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