FDA Inspection
CooperSurgical, Inc.CooperSurgical, Inc. – FDA Inspection, Jan 16, 2013
Record Details
This FDA Inspection record concerns CooperSurgical, Inc., with an inspection on January 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CooperSurgical, Inc.
- Inspection Date
- January 16, 2013
- Product Type
- Devices
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ID · bee043b5-d642-47ff-bced-cea651ef2a0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 815766
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - simulated testing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CooperSurgical, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 15, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CooperSurgical, Inc.
- FDA Inspection 1236656 - 2024-05-21
- FDA Inspection 1209056 - 2023-05-16
- FDA Inspection 1146202 - 2021-07-15
- FDA Inspection 1042445 - 2017-12-07
- FDA Inspection 1007880 - 2017-03-28
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