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# Amphastar Subsidiary Gets Warning Letter for California Facility
- URL: https://www.fdaweb.com/amphastar-subsidiary-gets-warning-letter-for-california-facility/
- Published: 2026-07-08T12:00:00.000Z
- Updated: 2026-09-14T13:42:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161422

FDA has sent Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, CA drug manufacturing facility. In a Securities and Exchange Commission filing, Amphastar says the 7/2 letter stems from an FDA inspection conducted back in December. At the conclusion of the inspection, investigators issued an FDA Form 483 identifying objectionable conditions observed during the inspection.

According to the filing, the Warning Letter cites deficiencies involving the facility's investigation procedures, environmental monitoring and handling practices, and manufacturing equipment. The company did not disclose specific observations identified by the agency.

Despite the findings, Amphastar says the letter does not direct IMS to stop manufacturing products at the facility or restrict product distribution. The letter also does not require any additional product recalls, although the company notes that remains subject to third-party verification.

IMS continues to manufacture and supply products from the South El Monte facility while implementing corrective actions, the company adds.

Amphastar says it has already implemented, and continues to implement, corrective actions in response to both the Form 483 observations and the Warning Letter.

The company is evaluating the potential impact of the Warning Letter on its business operations but cautions that it cannot assure investors that FDA will find its remediation efforts satisfactory or predict how long it will take to resolve the agency's concerns.