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

Source: https://www.globalkeysolutions.net/records/warning_letter/advanced-microvas-ii-llc/81ffe54c-8649-462b-a520-28d20f1dba48

> FDA WARNING_LETTER for Advanced MicroVas II, LLC on November 18, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Advanced MicroVas II, LLC
- Inspection Date: 2013-11-18
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.globalkeysolutions.net/companies/advanced-microvas-ii-llc/d99015e4-2e36-4455-9819-c82f3719278c

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9