FDA Inspection
Cook IncorporatedCook Incorporated – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Cook Incorporated, with an inspection on May 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · 7ba55491-dbf7-4fc9-b0ab-99c7e8b8e636
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011967
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Cook Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cook Incorporated
- FDA Inspection 845571 - 2013-07-30
- FDA Inspection 640284 - 2010-01-20
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