FDA 483 - Sanitor Corporation - June 03, 2021

Sanitor Corporation, a drug product manufacturer in Stanton, CA, was inspected by the FDA from May 25 to June 3, 2021. The inspection revealed significant deficiencies across quality control, production, laboratory controls, and personnel training, particularly concerning the release of drug products without complete testing, inadequate investigations into microbial failures, and issues with data integrity and stability programs. These findings indicate a systemic lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.