FDA Inspection
Pixation Corp.Pixation Corp. – FDA Inspection, Jun 27, 2018
Record Details
This FDA Inspection record concerns Pixation Corp., with an inspection on June 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f2670b44-bbf8-4a61-8b66-645eb0032175
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057198
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
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