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

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.