FDA 483 - Lilly del Caribe, Inc - February 25, 2022

An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, a drug product manufacturer, revealed significant deficiencies in quality control laboratory practices. The firm failed to adequately investigate out-of-specification results, often invalidating them without confirmed root causes or extending investigations to other affected batches. Additionally, laboratory controls allowed for the manipulation of test parameters and recalculation of OOS results stemming from incorrect sample preparation, compromising data integrity.