Inovaker Lab S.A. de C.V.

Warning LetterOpen

Victor Manuel Escarcega Gomez CEO Inovaker Lab S.A. de C.V. Luis Quintanar Poniente 1105 Bella Vista 64410 Monterrey , N.L. MexicoFEI 3009028673Issued Feb 25, 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 3009028673.

Violations2

Issue DateFeb 25, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Inovaker Lab S.A. de C.V.
Location: Victor Manuel Escarcega Gomez CEO Inovaker Lab S.A. de C.V. Luis Quintanar Poniente 1105 Bella Vista 64410 Monterrey , N.L. Mexico
FEI Number: 3009028673
Country: Mexico
Issue Date: February 25, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Inovaker Lab S.A. de C.V. was cited for manufacturing Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, an unapproved new drug that was adulterated due to subpotency—its active ingredient strength fell below the labeled 75% concentration—indicating failure of quality assurance systems to meet Current Good Manufacturing Practice (CGMP) requirements. The product was detained and refused admission at the U.S. border during an import attempt, and FDA testing confirmed the strength, purity, and quality deficiencies. The company was also cited for misbranding the product and introducing it into interstate commerce without FDA approval, violations of sections 505(a), 502(a), and 502(ee) of the Federal Food, Drug, and Cosmetic Act.

Inovaker Lab S.A. de C.V. FDA Warning Letter, February 25, 2021