FDA Inspection
Cook IncorporatedCook Incorporated – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns Cook Incorporated, with an inspection on January 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cook Incorporated
- Inspection Date
- January 20, 2010
- Product Type
- Devices
View Company Profile
ID · 58b55083-1aa0-4a69-a79c-3728655ddf32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640284
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.25(b)(2)Training on verification/validation defects
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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Other FDA inspections of Cook Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Cook Incorporated
- FDA Inspection 1011967 - 2017-05-26
- FDA Inspection 845571 - 2013-07-30
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