FDA Inspection
OPTIMOTION IMPLANTS LLCOPTIMOTION IMPLANTS LLC – FDA Inspection, Oct 20, 2023
Record Details
This FDA Inspection record concerns OPTIMOTION IMPLANTS LLC, with an inspection on October 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c799c3bb-13c6-41af-8446-f19d2089aba3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220841
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
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