• Amphastar unit International Medication Systems received an FDA warning letter on July 2, 2026 over CGMP issues at its South El Monte, California plant.
• Letter followed a December 2025 FDA inspection; concerns covered investigation procedures, environmental monitoring, handling procedures, manufacturing equipment.
• FDA did not order production limits or additional recalls; International Medication Systems continues supplying products while executing remediation.
• Initial response due within 15 working days; FDA also requested a risk assessment and remediation plan.
• Amphastar is assessing business impact; it warned the FDA may take further action until deficiencies are resolved.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amphastar Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001297184-26-000041), on July 08, 2026, and is solely responsible for the information contained therein.