FDA Inspection
Evergreen Orthopedic Research Lab, LLCEvergreen Orthopedic Research Lab, LLC – FDA Inspection, Apr 12, 2019
Record Details
This FDA Inspection record concerns Evergreen Orthopedic Research Lab, LLC, with an inspection on April 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d07ce2e3-9e92-4371-b160-ac918d7a30f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086103
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Evergreen Orthopedic Research Lab, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Evergreen Orthopedic Research Lab, LLC
- FDA Inspection 945848 - 2015-10-29
- FDA Inspection 852501 - 2013-11-01
- FDA Inspection 723717 - 2011-05-05
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