Christine Esposito, Managing Editor02.24.21
In its latest release notice provided by the US Food & Drug Administration, Absara Cosmetics S.A.P.I DE C.V., Zapata, Mexico, has been issued a warning letter from after the agency conducted testing of its consumer hand sanitizer. The product in question, labeled “Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free” formulated with 70% alcohol with aloe vera an glycerin it was detained and refused admission at the border.The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated according to the Federal Food, Drug, and Cosmetic Act as it contained only 58% v/v ethanol.
On October 16, 2020, FDA held a teleconference with the company, and it requested additional information concerning Absara Cosmetics’s CGMP operations, including test methods for its finished drug product, documentation showing equivalence with USP test methods, and the firm’s investigation into the subpotent lot tested by FDA. In the company’s responses, Absara Cosmetics provided details on the in-house testing that it is using to test its drug products, but did not provide any documentation for method validation or describing equivalence to relevant USP test methods, according to FDA. 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 (see 21 CFR 211.160).
FDA has requested a detailed follow-up investigation into how the hand sanitizer drug products described above, which were labeled as containing 70% ethanol, in fact contained an average of 58% ethanol, respectively. This follow-up investigation should identify the specific batches in each identified import entry that may have been impacted, and include a thorough review of laboratory methods and procedures used to analyze the impacted batches. FDA has also requested a list of all raw materials used to manufacture the hand sanitizer drug products, including the suppliers’ names, addresses, and contact information; and a list of all batches of any hand sanitizer drug products shipped to the United States by Absara Cosmetics, and a full reconciliation of all material it distributed.
On October 16, 2020, FDA held a teleconference with the company, and it requested additional information concerning Absara Cosmetics’s CGMP operations, including test methods for its finished drug product, documentation showing equivalence with USP test methods, and the firm’s investigation into the subpotent lot tested by FDA. In the company’s responses, Absara Cosmetics provided details on the in-house testing that it is using to test its drug products, but did not provide any documentation for method validation or describing equivalence to relevant USP test methods, according to FDA. 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 (see 21 CFR 211.160).
FDA has requested a detailed follow-up investigation into how the hand sanitizer drug products described above, which were labeled as containing 70% ethanol, in fact contained an average of 58% ethanol, respectively. This follow-up investigation should identify the specific batches in each identified import entry that may have been impacted, and include a thorough review of laboratory methods and procedures used to analyze the impacted batches. FDA has also requested a list of all raw materials used to manufacture the hand sanitizer drug products, including the suppliers’ names, addresses, and contact information; and a list of all batches of any hand sanitizer drug products shipped to the United States by Absara Cosmetics, and a full reconciliation of all material it distributed.