FDA Inspection
Stryker CorporationStryker Corporation – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns Stryker Corporation, with an inspection on March 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stryker Corporation
- Inspection Date
- March 22, 2011
- Product Type
- Devices
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ID · f2ff72a2-6fe7-40d1-82c1-5b5b682f2e45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716353
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Stryker Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 25, 2018 | Not classified | San Francisco District Office | |
| August 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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