Wednesday, 27 March 2024 11.00 - 16.30 h
In mid-November, the FDA sent a Warning Letter to the Turkish company Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi. This is a manufacturer of cosmetics, detergents and cleaning products. The product range also includes ethanol-based alcoholic hand disinfectants.
The FDA identified a number of omissions. On the one hand, the components used for production were not sufficiently tested in-house, and on the other hand, there was no reliable proof that the analyses performed by the supplier of the components were valid. This should have been done at regular intervals. Although Sudesan submitted documents at the FDA's request, these were inadequate and showed that the relevant physical and microbiological tests only began after these drugs had been shipped to the United States. The FDA points out in particular that ethanolic products have a risk of methanolic contamination and, due to the risk of poisoning, the FDA guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol must be observed.
Furthermore, no adequate laboratory testing of the individual batches was carried out prior to release to ensure conformity with the final specifications. Neither the clear identity of the active ingredients nor the active ingredient content were ensured. The FDA formulated as follows:
"Specifically, you were unable to demonstrate that you tested the identity and strength of the active ingredient in your Amoray Hand Sanitizers. In response to our request for release test specifications, analytical procedures for drug product analysis, and test data, you submitted, in part, a procedure stating that you evaluated the alcohol concentration and microbiological properties of your hand sanitizers. However, the COA reports submitted indicate that your hand sanitizers were only tested for appearance, odor, density, and pH."
Finally, the FDA criticized the fact that there was also insufficient data on the stability of the product, i.e. there was no evidence of the product's shelf life under appropriate storage conditions. The data provided only concerned a shelf life of 12 weeks under controlled room temperature conditions and had only been collected for goods from 2019. No data was provided to the FDA for the current batches.
The FDA advises the company to conduct a GMP consultation and placed the product on the import alert list (Import Alert 66-40) in October.
Further and more detailed information can be found in Warning Letter 320-24-05 on the FDA website.