FDA WARNING_LETTER - Erkul Kozmetik Sanayi ve Ticaret A.S. - August 01, 2025

The FDA issued a warning letter on June 2, 2026, to Erkul Kozmetik Sanayi ve Ticaret A.S., a Turkey-based manufacturer of over-the-counter drug products. This warning follows a comprehensive review of records requested in August 2025, which revealed significant failures to meet Current Good Manufacturing Practice (CGMP) standards under the Federal Food, Drug, and Cosmetic Act. The investigation identified two major violations. First, the company failed to adequately test raw materials, particularly talc, for identity and purity. Because talc carries a high risk of asbestos contamination—a known carcinogen—the FDA emphasized that the firm’s lack of validated testing and reliance on incomplete supplier data posed a safety risk. Second, the facility’s Quality Control Unit failed to provide proper oversight, allowing materials to be used in production without meeting established pharmaceutical specifications. Due to these findings, the FDA placed the firm on an import alert in March 2026. To regain compliance, Erkul Kozmetik must perform safety testing on retain samples, conduct a full risk assessment for products currently in distribution, and submit a detailed plan to improve their quality management systems. The company has 15 working days to respond with a schedule for these corrective actions.