FDA 483 - Lilly del Caribe, Inc. - February 17, 2023

An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, revealed two significant observations regarding quality unit failures. The firm failed to thoroughly investigate a microbial contamination discrepancy in a drug substance batch, leading to insufficient corrective actions. Additionally, the quality unit did not properly review and approve batch records and quality-related documents, resulting in manufacturing issues due to unapproved and untrailed procedural changes.