Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.

Warning LetterOpen

Mr. Juan Pablo Maza Gomez CEO Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. Calle Curtidores No. 38 Zona Industrial Xhala 54714 Cuautitlan , Méx. MexicoFEI 3015851305Issued Sep 29, 2021Center for Drug Evaluation and Research | CDER

View Letter

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 3015851305.

Violations3

Issue DateSep 29, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.
Location: Mr. Juan Pablo Maza Gomez CEO Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. Calle Curtidores No. 38 Zona Industrial Xhala 54714 Cuautitlan , Méx. Mexico
FEI Number: 3015851305
Country: Mexico
Issue Date: September 29, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Healthy Foods & Nutrition Lab de Mexico was warned for manufacturing HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION, an unapproved new drug that was adulterated due to subpotent active ingredient levels that fell below labeled strength. FDA testing of a batch detained at the U.S. border revealed the product failed to meet Current Good Manufacturing Practice (CGMP) requirements, demonstrating inadequate quality assurance controls at the facility. The product also violated regulations by being introduced into interstate commerce without FDA approval and was misbranded under multiple sections of the FD&C Act.

Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. FDA Warning Letter, September 29, 2021