FDA Inspection
Orbital Therapy LLCOrbital Therapy LLC – FDA Inspection, Oct 23, 2012
Record Details
This FDA Inspection record concerns Orbital Therapy LLC, with an inspection on October 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orbital Therapy LLC
- Inspection Date
- October 23, 2012
- Product Type
- Devices
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ID · e1bd22eb-cec8-40c3-8cbf-24a221195b85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804902
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Orbital Therapy LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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