Superior Glove Works, Ltd.

Warning LetterOpen

Mr. Tony Geng Owner and President Superior Glove Works, Ltd. Acton ON L7J 1S1 CanadaFEI 3006217765Issued Dec 16, 2022Center 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 3006217765.

Violations4

Issue DateDec 16, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Superior Glove Works, Ltd.
Location: Mr. Tony Geng Owner and President Superior Glove Works, Ltd. Acton ON L7J 1S1 Canada
FEI Number: 3006217765
Country: Canada
Issue Date: December 16, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Superior Glove Works, Ltd. was warned for manufacturing adulterated over-the-counter hand sanitizer products (Synergy Hand Sanitizer 80% and Synergy Hand Sanitizer with Aloe 70%) that violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company's ethanol active pharmaceutical ingredient (API) contained unacceptable impurity levels, including acetaldehyde at 205 ppm and total impurities at 2,846 ppm; acetaldehyde is genotoxic and potentially carcinogenic when in direct contact with tissues. The FDA requested the company remove affected batches from U.S. distribution following a teleconference on August 30, 2022, and the facility's drug manufacturer registration was terminated on August 25, 2022.

Superior Glove Works, Ltd. FDA Warning Letter, December 16, 2022