FDA 483 - TG Labs LLC - October 29, 2021
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TG Labs LLC, a drug manufacturer in Centennial, CO, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across quality control, production, and laboratory operations, indicating a systemic lack of documented procedures, investigations, and proper record-keeping for drug product manufacturing and release. These issues suggest a moderate to severe level of non-compliance with good manufacturing practices.
ID · 6860f947-50d0-4f77-ac34-60cce51f3ff3