FDA 483 - McNeil PPC Inc. - July 31, 2008

The FDA Form 483 details multiple observations regarding a pharmaceutical manufacturing facility. A primary concern is the inadequate investigation of complaints, particularly those "autoclosed" in the electronic Product Quality Management System (PQMS) without determining if they relate to production or design nonconformities. Examples include Visine for Contacts adverse event complaints (Tracking Nos. 30000084439, 30000084307, 300000083712, 30000103643, 30000104112) and Visine complaints (30000101432, 30000104929) describing burning eyes, chlorine smell, and loss of eyesight, which were not forwarded to the Quality Unit for investigation.

Corrective and preventive action procedures (QAR Procedure No. 2222, Version 4.0) are incomplete, lacking provisions to consider product design activities as a potential cause of nonconformity. Furthermore, not all quality data sources are fully analyzed; monthly "ADVERSE EVENT REPORT FOR QUALITY CONTROL" reports contain abbreviated descriptions, preventing comprehensive analysis by the manufacturing location's Corrective and Preventive Action system.

Supplier quality requirements are not adequately established, specifically concerning the Consumer/BRM Compliance Agreement for the Management of Drug Safety and