Dr. Keith Burk
CEO
Avaria Health & Beauty Corp.
650 Jamieson Parkway, Unit 5
Cambridge ON N3C 0A5
CanadaFEI 3014583374Issued Sep 3, 2024Center for Drug Evaluation and Research (CDER)
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.
Violations4
Issue DateSep 3, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Avaria Health & Beauty Corp.
Location
Dr. Keith Burk
CEO
Avaria Health & Beauty Corp.
650 Jamieson Parkway, Unit 5
Cambridge ON N3C 0A5
Canada
FEI Number
3014583374
Country
Canada
Issue Date
September 03, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Avaria Health & Beauty Corp., a Canadian drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their over-the-counter drug products adulterated. During an April 2024 inspection, the FDA identified that the firm failed to conduct required identity testing on incoming drug components, including high-risk ingredients, and did not perform USP identification tests to verify component safety limits. The violations indicated inadequate quality assurance procedures for components used in manufacturing, with the firm unable to verify the identity of each component shipment and lot used in their OTC products.
Avaria Health & Beauty Corp. FDA Warning Letter, September 3, 2024