Eli Lilly and Company — FDA 483 Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

The written stability program for drug products does not include reliable, meaningful and specific test methods.

Representative samples are not taken of each shipment of each lot of components and drug product containers for testing or examination.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.