FDA 483 - TG Labs LLC - October 29, 2021

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.