FDA Warning Letter: Focus on Quality Control of APIs and Excipients

Testing active pharmaceutical ingredients and excipients is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the starting materials are released only after their quality was judged as satisfactory. The same applies to the release of finished products.

A Turkish OTC manufacturer has failed to implement these fundamental GMP requirements, as evidenced by a new Warning Letter from the U.S. Food and Drug Administration (FDA). The letter, dated 21 January 2025, refers to a review of documents submitted in response to an official request for records and other information.

Similar to other Warning Letters we have reported on in recent months (see, for example, our news from 29 January 2025, or 16 October 2024), this one also concerns hand sanitizing products.

The FDA criticizes that glycerin and propylene glycol were not tested for potential contamination with diethylene glycol (DEG) or ethylene glycol (EG), despite the fact that these toxic substances have previously led to fatal poisonings. Likewise, ethanol was not tested for possible methanol contamination. Furthermore, the company did not conduct sufficient laboratory testing to confirm the identity and strength of the active ingredients (e.g., ethanol and benzalkonium chloride) prior to product release. Overall, the documentation did not indicate that the company’s Quality Unit adequately fulfilled its function, particularly in approving or rejecting raw materials and finished products.

The FDA has placed the company on Import Alert 66-40 (“Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs”), preventing its products from entering the United States. The company has been instructed to outline corrective actions for the deficiencies within 15 working days. Furthermore, the agency recommends engaging an external CGMP consultant to ensure a thorough review and improvement of processes.

For more information, please refer to the complete Warning Letter issued to Kardesler Ucan Yaglar Sanayi Anonim Sirketi, available on the FDA's website.