Diora Kimya Sanayi ve Ticaret Limited Sirketi Warning Letter Details

Summary

Diora Kimya Sanayi ve Ticaret Limited Sirketi, a Turkish drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceuticals, including failure to conduct identity tests on drug components and failure to validate supplier test analyses as required by 21 CFR 211.84(d)(1). The company's Personal CARE Antibacterial Soap product (NDC 72133-049) was found to be adulterated and misbranded because it was not duly listed with the FDA as required by section 510(j) of the Federal Food, Drug, and Cosmetic Act. These compliance failures rendered the drug product unsuitable for interstate commerce and subject to enforcement action.