FDA 483 - Eli Lilly & Company - March 16, 2021

This FDA Form 483 document outlines several significant observations made during an inspection of a pharmaceutical manufacturing facility. The firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, which is critical for preventing contamination of sterile drug products. A major deficiency noted was the failure to thoroughly investigate unexplained discrepancies or failures of batches or components to meet specifications, even for distributed batches.

The facility also lacked appropriate written procedures designed to prevent microbiological contamination of sterile drug products, specifically failing to validate aseptic and sterilization processes. Furthermore, employees involved in manufacturing, processing, packing, and holding drug products lacked the necessary training for their assigned functions. The written stability program for drug products was found to be inadequate, as it did not include reliable, meaningful, and specific test methods.

Additionally, the firm did not take representative samples from each shipment of each lot of components and drug product containers for testing or examination. Finally, the establishment of laboratory control mechanisms, including any changes, was not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit, indicating a breakdown in quality oversight. These observations highlight critical deficiencies in quality control, aseptic processing, training, and laboratory practices.