Avaria Health & Beauty Corp.

Warning LetterOpen

Juston Sharratt President Avaria Health & Beauty Corp. 650 Jamieson Pkwy Unit 5 Cambridge ON N3C 0A5 Canada juston@avariahb.comFEI 3014583374Issued Aug 3, 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 3014583374.

Violations3

Issue DateAug 3, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Avaria Health & Beauty Corp.
Location: Juston Sharratt President Avaria Health & Beauty Corp. 650 Jamieson Pkwy Unit 5 Cambridge ON N3C 0A5 Canada juston@avariahb.com
FEI Number: 3014583374
Country: Canada
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Avaria Health & Beauty Corp., a manufacturer of over-the-counter drug products including hand sanitizers and topical products, was cited for significant Current Good Manufacturing Practice (CGMP) violations that resulted in adulterated drugs. The company failed to conduct required identity testing on incoming drug components, specifically failing to adequately test glycerin and other high-risk ingredients for contamination with diethylene glycol (DEG) or ethylene glycol (EG). This violation of 21 CFR 211.84(d)(1) represented a critical gap in component verification procedures that the FDA deemed insufficient to ensure product safety and identity.

Avaria Health & Beauty Corp. FDA Warning Letter, August 3, 2023