FDA Inspection
Chemence Medical Products Inc.Chemence Medical Products Inc. – FDA Inspection, Nov 21, 2017
Record Details
This FDA Inspection record concerns Chemence Medical Products Inc., with an inspection on November 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b348352b-4e48-46d2-bcd5-170f1361e51e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031823
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.75(a)Documentation
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