Soliteint Kozmetikai KFT – FDA Warning Letter, Apr 19, 2024

The FDA issued a Warning Letter to Soliteint Kozmetikai KFT following an inspection from April 15-19, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals. The firm's drug products are deemed adulterated.

Key violations include: 1. **Inadequate Finished Product Testing:** Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications, including identity and strength of active ingredients, and testing for objectionable microorganisms, prior to release for OTC external analgesic drug products. 2. **Insufficient Component Testing:** Failure to verify the identity of each component, validate supplier test analyses, adequately test component water (including for total organic carbon and biofilm-forming microbes like *Burkholderia cepacia complex*), and perform identity testing for high-risk components like glycerin to ensure absence of diethylene glycol (DEG) or ethylene glycol (EG). 3. **Lack of Process Validation:** Failure to establish adequate written procedures for production and process control, specifically not conducting process validations for OTC drug products intended for the U.S. market. 4. **Deficient Quality Control Unit (QCU) Oversight:** The QCU failed to ensure CGMP compliance and meet specifications. The firm lacked adequate procedures for an effective Quality Management System, including CAPA, quality status labeling, and control of master batch records, and did not perform adequate stability testing to support assigned expiration dates.

The firm