FDA WARNING_LETTER - Advanced MicroVas II, LLC - November 18, 2013

An FDA inspection of Advanced MicroVas II LLC (Broken Arrow, Oklahoma) from July 9 to November 18, 2013, revealed that their Micro VAS8110 devices are adulterated and misbranded. As a specification developer, the firm failed to conform to Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key QS violations include: 1. Failure to establish design control procedures (21 CFR 820.30(a)), lacking procedures for design inputs, outputs, verification, validation, changes, and history files. 2. Inadequate complaint handling procedures (21 CFR 820.198), with no written procedures for receiving, reviewing, or evaluating complaints. 3. Absence of purchasing control procedures (21 CFR 820.50) for contract manufactured devices, lacking evaluation controls for suppliers or records of acceptable suppliers. 4. Failure to establish quality audit procedures (21 CFR 820.22) or conduct any audits since July 2, 2012. 5. Failure to maintain a device master record (21 CFR 820.181) for approximately (b)(4) distributed units.

MDR violations include: 1. Failure to adequately develop