FDA Inspection
Stryker Medical Division of Stryker CorporationStryker Medical Division of Stryker Corporation – FDA Inspection, Mar 1, 2017
Record Details
This FDA Inspection record concerns Stryker Medical Division of Stryker Corporation, with an inspection on March 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 1, 2017
- Product Type
- Devices
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ID · cf8fa029-7a68-4c0a-a660-ddbd339cea2a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003139
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Stryker Medical Division of Stryker Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | Detroit District Office | Compliance: Medical Devices |
| October 13, 2016 | Not classified | Detroit District Office | |
| June 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 15, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stryker Medical Division of Stryker Corporation
- FDA Inspection 1255124 - 2024-11-15
- FDA Inspection 996318 - 2016-10-13
- FDA Inspection 791490 - 2012-06-26
- FDA Inspection 682480 - 2010-09-24
- FDA Inspection 584103 - 2009-05-15
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