Laavo Clean, S.A. de C.V.

Warning LetterOpen

Mr. Diego Velázquez Manager Laavo Clean, S.A. de C.V. Elías Flores Sur. No. 300 Apodaca Centro 66600 Ciudad Apodaca , N.L. MexicoFEI 3017301021Issued Aug 7, 2023Center 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 3017301021.

Violations1

Issue DateAug 7, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Laavo Clean, S.A. de C.V.
Location: Mr. Diego Velázquez Manager Laavo Clean, S.A. de C.V. Elías Flores Sur. No. 300 Apodaca Centro 66600 Ciudad Apodaca , N.L. Mexico
FEI Number: 3017301021
Country: Mexico
Issue Date: August 07, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Laavo Clean, S.A. de C.V., a Mexican drug manufacturer, was warned that its hand sanitizer products labeled as containing 0.13% benzalkonium chloride (BZK) were adulterated because testing of batches detained at the U.S. border revealed strength variations exceeding acceptable limits—one product contained 115% of the labeled claim while another contained only 92.7%, both falling outside USP specifications of 93.0-107.0%. The adulteration violations involved two products: Instant Hand Sanitizer LaavoClean without Alcohol and Instant Hand Sanitizer LaavoClean KIDS without Alcohol, which were rejected upon attempted importation into the United States due to these strength deficiencies and exceedances.

Laavo Clean, S.A. de C.V. FDA Warning Letter, August 7, 2023