FDA 483 - CosMedical Technologies, LLC - July 07, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · ae30c274-e467-4e04-a5f0-5c6f0e14e781