Diora Kimya Sanayi ve Ticaret Limited Sirketi – FDA Warning Letter, May 31, 2024

The FDA inspected Diora Kimya Sanayi ve Ticaret Limited Sirketi from May 27-31, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated. The "Personal CARE Antibacterial Soap (NDC 72133-049)" was also not duly listed with the FDA, making it misbranded.

Key violations include: 1. **Failure to conduct identity testing for components and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not adequately test components, including those susceptible to DEG/EG contamination, and relied on supplier COAs without validation. Their response regarding suspending use and reviewing inventory was deemed inadequate due to lack of detail on supplier qualification and testing of retain samples. 2. **Failure to perform appropriate final product testing prior to release (21 CFR 211.165(a))**: Assay testing was not performed on numerous batches, including those distributed to the U.S. market. Component test results were directly transcribed to finished product COAs without confirmation. The firm's response to develop assay methods and revise SOPs was inadequate as it lacked a risk assessment or retrospective review of released products. 3. **Failure to establish written procedures for production and process control (21