FDA Inspection
Stryker Sustainability Solutions, Inc.Stryker Sustainability Solutions, Inc. – FDA Inspection, Feb 7, 2012
Record Details
This FDA Inspection record concerns Stryker Sustainability Solutions, Inc., with an inspection on February 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 7, 2012
- Product Type
- Devices
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ID · a09ae149-c3f5-4e32-a775-fa54c618fc96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766627
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Stryker Sustainability Solutions, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2019 | Not classified | Florida District Office | |
| June 26, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stryker Sustainability Solutions, Inc.
- FDA Inspection 1096624 - 2019-01-18
- FDA Inspection 932568 - 2015-06-26
- FDA Inspection 540814 - 2008-10-07
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