FDA 483 - Time-Cap Laboratories, Inc. - April 24, 2025

During an inspection, Time-Cap Laboratories, Inc., a human drug manufacturer in Farmingdale, NY, was cited for unsuitable building construction and maintenance practices. Specifically, issues were noted in blending room #2, including an unevaluated support beam, a detached air compression hose, and moldy residue on walls, indicating a lack of proper cleaning and quality unit oversight. These conditions raise concerns about potential contamination and adherence to Good Manufacturing Practices.