FDA WARNING_LETTER - Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi - December 26, 2023

This FDA Warning Letter (No: 320-24-05, November 13, 2023) was issued to Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi (FEI 3004647124) for significant Current Good Manufacturing Practice (CGMP) violations regarding their OTC drug products, including Amoray Instant Hand Sanitizer. The FDA reviewed records submitted on March 11, 2022, in response to an August 26, 2021 request.

The facility's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act due to non-conforming manufacturing methods, facilities, or controls. Specific violations include: 1. **Failure to conduct identity testing for each component and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2))**: Inadequate testing of incoming components, including ethanol, was observed. 2. **Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.165(a))**: Inadequate finished product testing, specifically lacking identity and strength testing for the active ingredient in Amoray Hand Sanitizers. 3.