FDA Inspection
Cook Biotech, Inc.Cook Biotech, Inc. – FDA Inspection, Sep 25, 2015
Record Details
This FDA Inspection record concerns Cook Biotech, Inc., with an inspection on September 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cook Biotech, Inc.
- Inspection Date
- September 25, 2015
- Product Type
- Devices
View Company Profile
ID · 5df3415c-bf00-4072-b54e-d73d011a17d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Cook Biotech, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 5, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cook Biotech, Inc.
- FDA Inspection 1094943 - 2019-07-01
- FDA Inspection 840289 - 2013-07-16
- FDA Inspection 695491 - 2010-10-05
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