FDA 483 - LeMaitre Vascular, Inc. - November 14, 2022

During an inspection conducted from October 24 to November 14, 2022, the FDA issued a Form 483 to Davion, Inc., a manufacturer of Over-The-Counter (OTC) drug products located in South Hackensack, NJ. The inspection revealed multiple significant deviations from Good Manufacturing Practices (GMP), several of which were repeat observations from previous inspections in 2012 and 2015. Key findings included the absence of a written stability testing program for OTC drug products, with very limited stability data available for over 300 products. Davion, Inc. also failed to conduct essential identity and strength testing for active ingredients in both incoming raw materials and finished drug products, instead relying on unverified Certificates of Analysis from suppliers and contract manufacturers. Further observations detailed a lack of written procedures for equipment cleaning and maintenance, including an absence of cleaning validation studies. The firm also failed to perform process validation for its OTC drug products. The Quality Control Unit demonstrated a lack of critical oversight, failing to review and approve batch records prior to product release. Finally, Davion, Inc. lacked a formal written procedure for handling drug product complaints. The company must address these deficiencies to ensure compliance with regulatory standards for drug product manufacturing.