Absara Cosmetics S.A.P.I DE C.V.

Warning LetterOpen

Mr. Daniel Chamlati Chief Executive Officer Absara Cosmetics S.A.P.I DE C.V. Autopista Mexico – Toluca Km. 53.5 Av. Ind. Farmac. Accesso Parque Industrial Dona Rosa Planta II 52004 Emiliano Zapata , MexicoFEI 3012333567Issued Feb 18, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012333567.

Violations3

Issue DateFeb 18, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Absara Cosmetics S.A.P.I DE C.V.
Location: Mr. Daniel Chamlati Chief Executive Officer Absara Cosmetics S.A.P.I DE C.V. Autopista Mexico – Toluca Km. 53.5 Av. Ind. Farmac. Accesso Parque Industrial Dona Rosa Planta II 52004 Emiliano Zapata , Mexico
FEI Number: 3012333567
Country: Mexico
Issue Date: February 18, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Absara Cosmetics S.A.P.I DE C.V. FDA Warning Letter, February 18, 2021