Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi Warning Letter Details

Summary

Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi, a Turkish manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their products adulterated. The company failed to conduct required identity testing on incoming drug components and did not validate or establish the reliability of their component suppliers' test analyses at appropriate intervals, as required by 21 CFR 211.84(d)(1) and 211.84(d)(2). These violations were identified following FDA review of records submitted in response to three separate information requests between June 2022 and July 2023.