FDA 483 - CosMedical Technologies, LLC - July 07, 2025

An FDA inspection of CosMedical Technologies, LLC, an OTC drug repacker and labeler in Davie, FL, revealed significant deficiencies in its quality control systems. The firm failed to perform essential finished product testing, manage customer complaints effectively, and adequately oversee contract manufacturers. Multiple procedural failures were noted, including a lack of batch record review, microbiological testing, annual product reviews, cGMP training, and proper label storage, alongside the absence of a stability testing program and incoming packaging material inspection.