FDA Inspection
The Phantom Laboratory IncThe Phantom Laboratory Inc – FDA Inspection, Dec 11, 2012
Record Details
This FDA Inspection record concerns The Phantom Laboratory Inc, with an inspection on December 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Phantom Laboratory Inc
- Inspection Date
- December 11, 2012
- Product Type
- Devices
View Company Profile
ID · 08f2d76a-4715-4cad-b0a2-6dac485cb59f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of The Phantom Laboratory Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for The Phantom Laboratory Inc
- FDA Inspection 685148 - 2010-10-12
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