Gulsah Uretim Kozmetik Sanayi Anonim Sirketi Warning Letter Details

Summary

Gulsah Uretim Kozmetik Sanayi Anonim Sirketi, a Turkish manufacturer of over-the-counter drug products, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The company failed to conduct adequate laboratory testing to confirm the identity and strength of active ingredients in drug batches prior to release for distribution to the U.S. market, in violation of 21 CFR 211.165(a). During FDA inquiries in July 2020 and January 2021, the company acknowledged that it did not perform required identity and strength testing for active pharmaceutical ingredients before releasing batches, rendering their drug products adulterated.