FDA 483 - L. Perrigo Company - July 28, 2005

An FDA inspection of L. Perrigo Company, a drug manufacturer in Allegan, MI, was conducted from July 19 to July 28, 2005. The inspection identified numerous deficiencies in the company's complaint handling procedures, indicating non-compliance with regulatory standards for drug manufacturing. Key observations included a systemic failure to follow established procedures for handling written and oral complaints regarding products such as infant APAP and cold/cough medications. The company did not consistently notify the Consumer Affairs Manager of serious product issues, including infant hospitalizations, in a timely manner. There was a general lack of timeliness in reviewing and responding to complaints, and significant complaint trends, particularly related to infant overdoses and confusing labeling, were not identified or addressed. Furthermore, the inspection revealed inadequate documentation regarding management reviews of complaints, evaluations, justifications for not conducting investigations, and approvals of closed complaint files. The Quality Control unit's role in reviewing complaints for potential product specification failures was also found to be insufficient. Investigations into discrepancies often failed to extend to other related products using similar delivery systems, and complaint records were not consistently maintained or readily accessible at the manufacturing site. These observations necessitate L. Perrigo Company to implement comprehensive corrective actions to align its complaint management processes with regulatory requirements.