FDA 483 - Vee Pak, LLC - December 10, 2024

Vee Pak, LLC, an OTC drug manufacturer in Hodgkins, IL, was cited for two significant issues during an FDA inspection. The firm failed to conduct adequate investigations into product discrepancies and out-of-specification results, particularly concerning SPF 70 drug product complaints and a lack of proper process change control for a raw material supplier change. Additionally, deficiencies were noted in laboratory controls, including improper storage of stability samples and a procedure allowing retesting into compliance without proper scientific justification for initial OOS results.