FDA Inspection
McGee Group, Inc. (The)McGee Group, Inc. (The) – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns McGee Group, Inc. (The), with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c0d3e7ef-ea9a-4e85-8b34-0993a637a795
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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