FDA Inspection
Cook IncorporatedCook Incorporated – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Cook Incorporated, with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cook Incorporated
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · 5a4a41d7-a6a5-49a7-bbdb-c456e14b0aa4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799661
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 820.250(b)Sampling plans
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cook Incorporated
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2025 | Not classified | Detroit District Office | Compliance: Medical Devices |
| May 8, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 7, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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