FDA 483 - TG Labs, Inc. - September 29, 2022

TG Labs, Inc. in Centennial, CO, a manufacturer of Tetracycline 3% Ointment, was cited for significant deficiencies in its quality control unit, laboratory practices, and facility controls during an FDA inspection. The observations highlight issues with written procedures, record-keeping, equipment calibration, and prevention of contamination and mix-ups. Several observations were removed after discussion, indicating some resolution or clarification during the inspection.