By Connor Hart


Amphastar Pharmaceuticals said one of its subsidiaries received a warning letter from the Food and Drug Administration regarding one of its facilities, citing violations of current good manufacturing practices.

The company on Wednesday said observations in the letter--concerning International Medication Systems' manufacturing facility in South El Monte, Calif.--relate to investigation procedures, environmental monitoring and handling procedures, as well as manufacturing equipment.

The letter doesn't require the company to cease or restrict operations, nor issue a recall, Amphastar said.

Amphastar and International Medication Systems said they are taking the matters identified in the letter seriously, and are working to implement a remediation plan.


Write to Connor Hart at connor.hart@wsj.com


(END) Dow Jones Newswires

07-08-26 0638ET