FDA 483 - Lilly del Caribe, Inc - July 23, 2013

Lilly del Caribe, Inc. in Carolina, PR, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including inadequate investigations into consumer complaints about capsule defects, failure to submit required field alert reports, and a quality control unit that did not properly manage nonconforming materials. Additionally, the facility suffered from recurring microbial contamination in manufacturing areas due to environmental control deficiencies.