Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil Warning Letter Details

Summary

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, a Turkish drug manufacturer, was cited for manufacturing an adulterated antiseptic hand rub product that contained only 59% ethanol by volume instead of the labeled concentration, failing to meet the active ingredient strength declared on the label. The product was detained at the U.S. border and FDA testing confirmed the subpotency violation under section 501(c) of the FD&C Act, indicating the company's quality assurance and Current Good Manufacturing Practice (CGMP) controls were not functioning adequately. The deficiency demonstrated systemic failures in the firm's manufacturing processes and quality oversight for this hand sanitizer product.