FDA Inspection
Medicrea InternationalMedicrea International – FDA Inspection, Jun 19, 2013
Record Details
This FDA Inspection record concerns Medicrea International, with an inspection on June 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medicrea International
- Inspection Date
- June 19, 2013
- Product Type
- Devices
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ID · d0fa13c3-254f-4803-9008-7b77d7b07566
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848044
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
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Other FDA inspections of Medicrea International
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medicrea International
- FDA Inspection 1003124 - 2017-02-16
- FDA Inspection 854720 - 2013-06-20
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