FDA Inspection
AMS Diagnostics, LLCAMS Diagnostics, LLC – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns AMS Diagnostics, LLC, with an inspection on April 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b114641e-3359-42bb-a903-4e813a4b008a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012883
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of AMS Diagnostics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AMS Diagnostics, LLC
- FDA Inspection 1115637 - 2020-01-21
- FDA Inspection 865910 - 2014-02-12
- FDA Inspection 780953 - 2012-05-02
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