FDA Inspection
Cook Biotech, Inc.Cook Biotech, Inc. – FDA Inspection, Jul 16, 2013
Record Details
This FDA Inspection record concerns Cook Biotech, Inc., with an inspection on July 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cook Biotech, Inc.
- Inspection Date
- July 16, 2013
- Product Type
- Devices
View Company Profile
ID · 0e9eb6e5-a11a-405c-893b-4ab6db31a986
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840289
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
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 |
| September 25, 2015 | 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 955632 - 2015-09-25
- FDA Inspection 695491 - 2010-10-05
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