Batrik Medical Mfg., Inc. – FDA Warning Letter, Jun 27, 2013

The FDA issued a Warning Letter to Batrik Medical Mfg., Inc. following an inspection from June 25-27, 2013, at their Dorval, Canada facility. The firm manufactures vascular silicone ties, classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The inspection revealed these devices are adulterated under section 501(h) because manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation, 21 CFR Part 820. Key violations include the failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically the (b)(4) process for vascular silicone ties. Additionally, the firm failed to establish and maintain procedures to control non-conforming product (21 CFR 820.90(a)), as their procedure did not address identification and segregation, and non-conforming products were not segregated or labeled. Lastly, the firm failed to maintain Device History Records (DHRs) to demonstrate manufacturing in accordance with the device master record (21 CFR 820.184), with DHRs lacking documentation of sterilization for all released product and showing discrepancies in quantities. The FDA requires a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable. Failure to correct violations may impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments. A follow-up inspection will be conducted to verify corrections.