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

Source: https://www.globalkeysolutions.net/records/warning_letter/saruhan-kimya-ve-temizlik-urunleri-sanayi-ticaret-anonim-sirketi-corlu-subesi/7c957f68-7b36-4935-8fa4-c0dff564851b

> FDA WARNING_LETTER for Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi on November 14, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi
- Inspection Date: 2023-11-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/saruhan-kimya-ve-temizlik-urunleri-sanayi-ticaret-anonim-sirketi-corlu-subesi/f654a70c-77a2-420b-b72c-b16e89811c6f

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c