FDA WARNING_LETTER - Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi - November 14, 2023

The FDA issued a Warning Letter to Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi, a manufacturer of OTC drug products, following a review of records requested under section 704(a)(4) of the FD&C Act. The facility's drug products are deemed adulterated due to significant Current Good Manufacturing Practice (CGMP) violations.

Key violations include: 1. **Failure to test component identity and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not demonstrate identity testing of incoming components, including ethanol for methanol, despite manufacturing ethanol-containing hand sanitizers. 2. **Failure to conduct adequate finished product testing (21 CFR 211.165(a) and 211.165(b)):** The firm did not perform identity testing on finished OTC drug products and omitted microbiological testing due to "high alcohol content," which FDA notes is insufficient to prevent contamination. 3. **Failure to establish an adequate stability testing program (21 CFR 211.166(a)):** The firm lacked sufficient stability data to support a two-year expiry period, providing only limited accelerated and long-term test results, and did not evaluate identity in these studies.

The FDA recommends engaging