FDA WARNING_LETTER - Gaza Proveedora De Servicios De Hospedaje Y Alimentacion - March 09, 2021

The FDA issued a Warning Letter to Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, a registered human drug manufacturer in Mexico, following the detention and testing of their Pristine Hand Sanitizer Gel at the U.S. border. FDA laboratory analysis revealed the product contained only 42% v/v ethanol, significantly below the labeled 68% and the CDC-recommended 60% minimum. This subpotency renders the product adulterated under sections 501(c) and 501(a)(2)(B) of the FD&C Act, indicating a failure in quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements. Furthermore, the product is an unapproved new drug under section 505(a) and 201(p) because it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It also fails to conform to the 1994 Tentative Final Monograph and subsequent amendments, thus not meeting conditions for marketing under section 505G. The hand sanitizer is also misbranded under sections 502(a) and 502(ee) due to false labeling regarding ethanol concentration and non-compliance with 505G requirements. Introduction of such adulterated and misbranded drugs into interstate commerce is prohibited by sections 301(d) and 301(a). The FDA recommends engaging a CGMP consultant. The firm must respond within 15 working days with a detailed subpotency investigation, raw material lists, batch records, and a reconciliation of distributed products. All the firm's drugs are currently on Import Alert 66-78, meaning they face detention or refusal of admission until compliance is demonstrated, potentially requiring an FDA inspection.