Absara Cosmetics S.A.P.I DE C.V. Warning Letter Details

Summary

Absara Cosmetics S.A.P.I DE C.V., a Mexican drug manufacturer, was cited for producing an adulterated hand sanitizer product labeled "FRAGRANCE FREE VLANC + PLUR HAND SANITIZER" that failed to meet its represented strength. FDA laboratory testing of a detained batch found the product contained significantly less than the labeled 70% alcohol content, constituting adulteration under FD&C Act sections 501(c) and 501(a)(2)(B). The subpotency violation indicated that the company's quality assurance systems were not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.