FDA WARNING_LETTER - Absara Cosmetics S.A.P.I DE C.V. - February 18, 2021

The FDA issued a Warning Letter to Absara Cosmetics S.A.P.I. De C.V. on February 18, 2021, following the detention and refusal of admission of their "FRAGRANCE FREE VLANC + PLUR HAND SANITIZER RINSE FREE FORMULATED WITH 70% OF ALCOHOL WITH ALOE VERA & GLYCERIN" product at the U.S. border. FDA testing revealed the product, labeled to contain 70% v/v ethanol, only contained 58% v/v, falling below the declared strength and the CDC's recommended minimum of 60% for hand sanitizers.

This subpotency renders the drug adulterated under section 501(c) of the FD&C Act. Furthermore, it indicates a failure of the firm's quality assurance to comply with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B). The firm's provided test methods for finished drug products lacked validation documentation, equivalence to USP methods, and contained errors, violating 21 CFR 211.160. Their investigation into the subpotent batch was deemed inadequate, failing to provide scientific justification for its limited scope and neglecting to review test methods or laboratory operations, violating 21 CFR 211.192.

The FDA recommends engaging a qualified CGMP