FDA 483 - Avaria Health & Beauty Corp - April 30, 2024

An FDA inspection of Avaria Health & Beauty Corp., an OTC drug manufacturer in Cambridge, Ontario, revealed multiple significant deficiencies. The firm failed to establish adequate laboratory controls, verify raw material identities, validate testing methods and manufacturing processes, and maintain proper equipment calibration programs. These issues indicate a lack of robust quality control and adherence to good manufacturing practices for drug products shipped to the U.S. market.