FDA Inspection
Collagen Matrix IncCollagen Matrix Inc – FDA Inspection, Jul 18, 2017
Record Details
This FDA Inspection record concerns Collagen Matrix Inc, with an inspection on July 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a90f0ae9-d2ca-4872-bc65-b0bdab4a5518
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018218
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Collagen Matrix Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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