FDA WARNING_LETTER - Sani-Care Salon Products, Inc. - November 03, 2023

The FDA issued a Warning Letter to Sani-Care Salon Products, Inc. following an inspection from October 31 to November 3, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals. The drug products are deemed adulterated.

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** The firm's QCU failed to ensure drug products comply with CGMP and meet specifications. This includes lacking an adequate QCU, not validating the water system, and not having a procedure to monitor water quality. Corrective actions require robust procedures, QCU oversight, complete batch reviews, and approval of investigations. 2. **Insufficient Finished Product Testing:** The firm failed to conduct appropriate laboratory testing for finished drug products, including identity, strength, impurity, and microbiological attributes. No finished drug product specifications were established since manufacturing began in November 2020. An action plan for testing retain samples of all distributed batches within expiry is required. 3. **Failure to Test Components:** The firm did not verify the identity of each component or validate supplier test analyses. Active pharmaceutical ingredient (API) was released based on a Certificate of Analysis (COA) without identity testing or validation. Additionally, expired API was used in production.

The FDA strongly recommends engaging a qualified CGMP consultant. The firm is responsible for the quality of drugs produced as a contract facility. Failure to address these violations