FDA Inspection
Cook Biotech, Inc.Cook Biotech, Inc. – FDA Inspection, Jul 1, 2019
Record Details
This FDA Inspection record concerns Cook Biotech, Inc., with an inspection on July 1, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b7880651-ba51-45e8-b2ee-b67a413e5fe9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094943
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.270(a)Records maintained concurrently
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cook Biotech, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 955632 - 2015-09-25
- FDA Inspection 840289 - 2013-07-16
- FDA Inspection 695491 - 2010-10-05
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