FDA Inspection
Cook IncCook Inc – FDA Inspection, Aug 28, 2012
Record Details
This FDA Inspection record concerns Cook Inc, with an inspection on August 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cook Inc
- Inspection Date
- August 28, 2012
- Product Type
- Devices
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ID · de8c4ab3-4170-407d-af82-e0680ed7e18e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798710
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Cook Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cook Inc
- FDA Inspection 971807 - 2016-03-31
- FDA Inspection 695113 - 2010-10-05
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