FDA Inspection
Collagen Matrix, Inc.FDA Inspection 628897 - Collagen Matrix, Inc. - November 10, 2009
Record Details
This FDA Inspection record concerns Collagen Matrix, Inc., with an inspection on November 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Collagen Matrix, Inc.
- Inspection Date
- November 10, 2009
- Product Type
- Devices
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ID · 2407c70d-ad52-42dc-996e-e9bbad961a6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628897
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Collagen Matrix, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 25, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Collagen Matrix, Inc.
- FDA Inspection 1021261 - 2017-07-13
- FDA Inspection 961411 - 2015-11-25
- FDA Inspection 758803 - 2011-12-05
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