FDA Inspection
Medicrea InternationalMedicrea International – FDA Inspection, Feb 16, 2017
Record Details
This FDA Inspection record concerns Medicrea International, with an inspection on February 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e89e9a9d-55fd-46d7-bb0c-b8d6833c48b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003124
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Medicrea International
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medicrea International
- FDA Inspection 854720 - 2013-06-20
- FDA Inspection 848044 - 2013-06-19
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