FDA 483 - Lilly del Caribe, Inc - January 30, 2026

An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, a drug product manufacturer, revealed two significant observations. The firm's quality control unit failed to maintain adequate controls over non-batch controlled forms, resulting in numerous missing documents. Additionally, the facility's buildings used for manufacturing and warehousing were found to be infested with various pests, indicating a lack of proper pest control.