FDA Inspection
Backjoy Orthotics LLCBackjoy Orthotics LLC – FDA Inspection, Mar 7, 2017
Record Details
This FDA Inspection record concerns Backjoy Orthotics LLC, with an inspection on March 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7c2390a-10ca-42c1-aebd-3bc3b8f7bacb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005610
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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