FDA 483 - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - March 05, 2026

From March 2 to March 5, 2026, the FDA inspected the Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil facility in Istanbul, Turkey, an over-the-counter (OTC) drug manufacturer. The inspection identified two primary categories of violations concerning product stability and material management. First, the firm failed to follow its written stability testing protocols. Investigators observed that stability samples were not properly labeled to distinguish between long-term and accelerated storage conditions. Additionally, the company could not explain how a single sample was sufficient for both internal and external laboratory testing, including microbial evaluations. Second, the facility failed to adequately identify and track manufacturing components and closures. Several containers in the quarantine area lacked required labeling, and the electronic inventory management system contained discrepancies, failing to accurately trace the status and location of specific lots. These findings suggest the firm is not meeting the necessary regulatory standards for quality control and inventory oversight. To address these issues, the company must provide the FDA with a detailed response outlining their corrective actions or objections to ensure future compliance with manufacturing safety and quality requirements.