FDA Inspection
Aero Data Metal Crafters IncAero Data Metal Crafters Inc – FDA Inspection, Jun 6, 2017
Record Details
This FDA Inspection record concerns Aero Data Metal Crafters Inc, with an inspection on June 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fe60e038-2d7f-479b-a211-0ed504f9b5fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013150
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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