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# CGMP Violations in Turkish OTC Drug Manufacturer
- URL: https://www.fdaweb.com/cgmp-violations-in-turkish-otc-drug-manufacturer/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155794

FDA says its review of records submitted by Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi, an over-the-counter drug manufacturer in Tekirdag, Turkey, in response to three FDA requests, found significant violations of current good manufacturing practice (CGMP) regulations. An 11/6 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/saruhan-kimya-ve-temizlik-urunleri-sanayi-ticaret-anonim-sirketi-corlu-subesi-669487-11062023?ref=fdaweb.com) says specific violations were:

- failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary; and
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates.

The agency recommends that the firm engage a qualified consultant to perform a comprehensive audit of the company’s entire operation for CGMP compliance and assist it in meeting requirements if it intends to resume making drugs for the U.S. market.

Saruhan was placed on an Import Alert on 10/27\. It was told to correct any violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.