FDA Inspection
Genesys Orthopedics Systems, LLCGenesys Orthopedics Systems, LLC – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Genesys Orthopedics Systems, LLC, with an inspection on September 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c983c277-852e-4d39-9b11-0703d3684538
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024529
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 806.10(a)(1)Report of risk to health
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genesys Orthopedics Systems, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 16, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 24, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 5, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Genesys Orthopedics Systems, LLC
- FDA Inspection 1221419 - 2023-08-10
- FDA Inspection 1116370 - 2020-01-16
- FDA Inspection 885278 - 2014-06-24
- FDA Inspection 834819 - 2013-06-05
- FDA Inspection 773496 - 2012-04-02
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