FDA Inspection
AMS Diagnostics, LLCAMS Diagnostics, LLC – FDA Inspection, Jan 21, 2020
Record Details
This FDA Inspection record concerns AMS Diagnostics, LLC, with an inspection on January 21, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AMS Diagnostics, LLC
- Inspection Date
- January 21, 2020
- Product Type
- Devices
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ID · 4d3b2a87-83fd-4c59-837e-b3c47a0527bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of AMS Diagnostics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2017 | 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 1012883 - 2017-04-28
- FDA Inspection 865910 - 2014-02-12
- FDA Inspection 780953 - 2012-05-02
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