FDA Inspection
Factor Medical IncFactor Medical Inc – FDA Inspection, Nov 26, 2018
Record Details
This FDA Inspection record concerns Factor Medical Inc, with an inspection on November 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cc9b91c4-9271-4b92-9d63-355b830696af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.75(a)Lack of or inadequate process validation
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