FDA Inspection
AMPCARE, LLCAMPCARE, LLC – FDA Inspection, Nov 15, 2017
Record Details
This FDA Inspection record concerns AMPCARE, LLC, with an inspection on November 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a15cc2be-85ed-4c30-9637-26bb15e314b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031825
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of AMPCARE, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AMPCARE, LLC
- FDA Inspection 1287414 - 2025-09-25
- FDA Inspection 1204300 - 2023-04-26
- FDA Inspection 902431 - 2014-11-04
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