FDA 483 - Tec Laboratories, Inc. - August 09, 2019

Tec Laboratories Inc. in Albany, OR, received a Form 483 with seven observations during an FDA inspection from August 6-9, 2019. The inspection revealed significant deficiencies across quality control, production, facility, equipment, and laboratory control systems, including issues with unapproved drug products, inadequate investigations, unverified balances, lack of change control, poor equipment maintenance, deficient HVAC qualification, and critical data integrity risks in the QC laboratory. These findings indicate a broad failure to adhere to GMP regulations.