Evi Labs LLC

Warning LetterOpen

Mr. Luis E. Echeverria President Evi Labs LLC 9110 NW 106th Street Medley , FL 33178 United StatesFEI 3014581785Issued May 14, 2025Center for Drug Evaluation and Research (CDER)

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Letter Details

Firm: Evi Labs LLC
Location: Mr. Luis E. Echeverria President Evi Labs LLC 9110 NW 106th Street Medley , FL 33178 United States
FEI Number: 3014581785
Country: United States
Issue Date: May 14, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Evi Labs LLC, a drug manufacturer in Medley, Florida, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their OTC topical drug products adulterated. During a January 2025 inspection, the FDA identified that the company released batches of aluminum chlorohydrate-containing antiperspirant products without adequate strength and identity testing prior to distribution, in violation of 21 CFR 211.165(a). Test results for released lots, including Zermat Kiwi Perfumado, showed aluminum chlorohydrate concentrations that significantly exceeded labeled amounts and failed to meet established specifications. The company's response to the FDA's Form 483 was deemed inadequate due to lack of supporting documentation and insufficient evidence of corrective actions.