MedOffice Saglik Endustri Anonim Sirketi Warning Letter Details

Summary

MedOffice Saglik Endustri Anonim Sirketi, a Turkish pharmaceutical manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished drug products during an FDA inspection in May 2024. The company failed to perform required laboratory testing on over-the-counter (OTC) drug products to verify the identity and strength of active ingredients prior to release and distribution into the U.S. market, in violation of 21 CFR 211.165(a) and (b). The firm's response to FDA's initial findings was deemed inadequate because it did not provide sufficient supporting documentation or adequate evidence of corrective actions to achieve CGMP compliance. As a result, the company's drug products were determined to be adulterated under the Federal Food, Drug, and Cosmetic Act.