FDA Inspection
Armedica Manufacturing CorpArmedica Manufacturing Corp – FDA Inspection, Dec 5, 2013
Record Details
This FDA Inspection record concerns Armedica Manufacturing Corp, with an inspection on December 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Armedica Manufacturing Corp
- Inspection Date
- December 5, 2013
- Product Type
- Devices
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ID · f0fac8f1-4c46-44af-a2e4-95d3c4245654
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857943
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Armedica Manufacturing Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Armedica Manufacturing Corp
- FDA Inspection 713387 - 2011-03-10
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