FDA 483 - Time-Cap Laboratories, Inc. - April 24, 2025
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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.
ID · 708a6db2-7ebb-4861-87b4-26b89a57313a