The FDA has slapped Puerto Rico-based AIAC Pharma with a six-observation Form 483 over complaint management, cleaning records and apparent lapses in laboratory controls.
According to the 483, the firm did not include its investigation findings regarding the odor and taste of Propecia tablets — which the facility manufactures — in its complaint records. Specifically, there was no designated root cause listed in the manufacturing or packaging, the agency says.
AIAC also was hit for supposedly failing to extend investigations of unexplained discrepancies to other products potentially associated with the failure. For example, investigations of manufacturing deviations for Janumet XR tablets identified a root cause and a corrective and preventive action plan for broken tablets during production, but the company did not correlate the customer complaints with previous investigations.