FDA 483 - Lilly del Caribe, Inc - September 21, 2018

Lilly del Caribe Inc. in Carolina, PR, was inspected and received a Form 483 with five observations related to significant deficiencies in their quality control, complaint handling, and manufacturing investigation systems. The observations highlight issues with incomplete laboratory records, unrecorded deviations, inadequate complaint investigations, insufficient documentation of manufacturing discrepancies, and deficient in-process material inspection procedures. These findings indicate a need for improved data integrity, procedural adherence, and comprehensive record-keeping across several critical areas.