FDA 483 - PharMEDium Services, LLC. - January 27, 2006

During an inspection, an unnamed pharmaceutical company received an FDA Form 483 citing multiple significant deviations from current Good Manufacturing Practices (cGMP). The observations primarily highlighted critical deficiencies in quality control, product testing, and procedural adherence. A central issue was the failure to perform essential finished product testing for identity, potency, and sterility for every lot prior to release, directly impacting product quality and patient safety. The Quality Control unit lacked proper written designation, responsibility, and authority to accept or reject materials and products. Furthermore, production technicians, not quality personnel, were improperly authorized to approve product labeling, compromising quality oversight. Procedural failures were also noted. Finished product quarantine and release procedures were inadequate, exemplified by the shipment of a quarantined lot of Hydromorphone HCl. In-process products lacked sufficient labeling, creating a risk of mix-ups. The company also failed to implement an ongoing stability program to validate product potency and sterility through expiration dates, and neglected to maintain required reserve samples. Inadequate line clearance in labeling areas, with multiple drug products present simultaneously, increased the risk of cross-contamination or mislabeling. Finally, the company failed to promptly initiate investigations into production deviations, particularly when quality assurance staff were not present, hindering timely corrective actions. The FDA observations require the company to promptly address these serious issues to ensure compliance with cGMP regulations and safeguard product quality.