FDA 483 - Lilly del Caribe, Inc - July 09, 2019

Lilly del Caribe, Inc. in Carolina, PR was inspected from July 9-12, 2019, and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, data integrity, and manufacturing process validation, particularly concerning NIR model maintenance, computer system controls, deviation classification, and investigation of non-conformances for Abemaciclib Tablets. These issues indicate a lack of robust quality management and control over critical manufacturing and testing processes.