FDA WARNING_LETTER - Sanitor Corporation - June 03, 2021

The FDA inspected Sanitor Corporation's drug manufacturing facility from May 25 to June 3, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures unapproved new drugs, specifically skin bleaching products, in violation of 21 U.S.C. 355(a), and some products are misbranded and not properly listed with the FDA.

Key violations include the quality control unit's failure to ensure CGMP compliance and product specifications. This manifested as inadequate investigations into microbial contamination in hand sanitizer batches, approving the addition of preservatives to failing or untested batches, and releasing products before complete testing. The stability program was also inadequate, lacking proper oversight and adherence to procedures. Furthermore, documentation practices were deficient, with non-contemporaneous record-keeping and a lack of data integrity controls for computerized systems like the FTIR.

The FDA cited 21 CFR 211.22, 211.160(b), and 211.68(b). The company's previous response to the FDA Form 483 was deemed inadequate. The FDA recommended engaging a CGMP consultant for quality risk management, data integrity, and investigations.

Sanitor Corporation is required to provide a comprehensive, independent assessment and remediation plan for their investigation, CAPA, stability, and documentation systems, including detailed corrective actions and timelines. They