Monday, 20 September 2021 14.00 - 15.30 h
The U.S. Food and Drug Administration (FDA) has recently stopped a delivery of hand sanitizer products labeled as containing 75% ethanol, but in fact containing only 58%. The product was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.
Now another shipment of a product has been stopped at the US border. This drug product was labeled to be manufactured at Absara Cosmetics S.A.P.I DE C.V. in Mexico and to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA laboratory testing of this product detained at the border found that the drug product contained only 58% v/v ethanol.
The FDA first held a teleconference with the company to discuss the test results. In a Warning Letter dated February 18, 2021, the FDA says that additional information concerning the CGMP operations at the Mexican facility, including test methods for the finished drug product, documentation showing equivalence with USP test methods, and the investigation into the subpotent lot tested by FDA were requested. The company provided details on the in-house testing that are used to test the drug products, but did not provide any documentation for method validation or describing equivalence to relevant USP test methods.
The FDA writes that "the methods provided showed differences from USP methods without justification and did not describe an internal standard, system suitability, and contained calculation errors. Failure to have adequate test methods is a violation of CGMP requirements."
In summary, the FDA came to the conclusion that the quality assurance within the company's facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
In response to the Warning Letter, the FDA requests, besides others,
Based upon the nature of the violations, the FDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements.
Furthermore, the FDA placed all drugs and drug products manufactured by the company on Import Alert 66-78, "as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices."
Please see the complete FDA Warning Letter to Absara Cosmetics S.A.P.I DE C.V. for more detailed information.