FDA Inspection
Demetech Corp.Demetech Corp. – FDA Inspection, Jul 27, 2011
Record Details
This FDA Inspection record concerns Demetech Corp., with an inspection on July 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Demetech Corp.
- Inspection Date
- July 27, 2011
- Product Type
- Devices
View Company Profile
ID · 54e3d88e-0ba4-4185-a24f-6f3d4d816602
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737178
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Demetech Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Demetech Corp.
- FDA Inspection 939089 - 2015-08-26
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