Amphastar Unit Receives US FDA Warning Letter on Violations at California Facility
Amphastar Pharmaceuticals (AMPH) unit International Medication Systems has received a warning letter from the US Food and Drug Administration on violations at its drug manufacturing facility in South El Monte, California, Amphastar said in a regulatory filing Wednesday. The letter received on July 2 cited violations of current Good Manufacturing Practice regulations for finished pharmaceuticals in relation to investigation procedures, environmental monitoring, handling, and manufacturing, Amphastar said. Amphastar said the letter does not direct its unit to cease or restrict products, but rather to conduct a risk assessment and implement a remediation plan while it continues manufacturing operations. The unit also does not have to recall further products, but that remains subject to third-party verification, Amphastar said. International Medication Systems is required to submit an initial response within 15 working days, the company said.
Amphastar Pharmaceuticals (AMPH) unit International Medication Systems has received a warning letter from the US Food and Drug Administration on violations at its drug manufacturing facility in South El Monte, California, Amphastar said in a regulatory filing Wednesday.
The letter received on July 2 cited violations of current Good Manufacturing Practice regulations for finished pharmaceuticals in relation to investigation procedures, environmental monitoring, handling, and manufacturing, Amphastar said.
Amphastar said the letter does not direct its unit to cease or restrict products, but rather to conduct a risk assessment and implement a remediation plan while it continues manufacturing operations.
The unit also does not have to recall further products, but that remains subject to third-party verification, Amphastar said.
International Medication Systems is required to submit an initial response within 15 working days, the company said.