FDA 483 - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - September 16, 2022

Delta Kozmetik Sanayi Ve Ticaret-Selim Yere, an OTC drug manufacturer in Istanbul, Turkey, was cited for significant deficiencies in its quality systems. The inspection revealed a lack of validated manufacturing processes, an inadequate stability program, failures in supplier qualification, and insufficient process controls for manufacturing equipment. These issues indicate a systemic failure to ensure drug product quality and compliance with cGMP regulations.