FDA Inspection
Collagen Matrix, Inc.FDA Inspection 961411 - Collagen Matrix, Inc. - November 25, 2015
Record Details
This FDA Inspection record concerns Collagen Matrix, Inc., with an inspection on November 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Collagen Matrix, Inc.
- Inspection Date
- November 25, 2015
- Product Type
- Devices
View Company Profile
ID · b36a0928-6222-4f86-93aa-e6c1b18f2764
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 961411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
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 |
| December 5, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Collagen Matrix, Inc.
- FDA Inspection 1021261 - 2017-07-13
- FDA Inspection 758803 - 2011-12-05
- FDA Inspection 628897 - 2009-11-10
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