FDA Inspection
IDEV Technologies, Inc.IDEV Technologies, Inc. – FDA Inspection, Jan 21, 2009
Record Details
This FDA Inspection record concerns IDEV Technologies, Inc., with an inspection on January 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- IDEV Technologies, Inc.
- Inspection Date
- January 21, 2009
- Product Type
- Devices
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ID · 1dfb92f0-9d61-4a42-9e71-7ba9369386e0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 556640
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(c)Incomplete, ambiguous, conflicting design requirements
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - unresolved discrepancies
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IDEV Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 10, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for IDEV Technologies, Inc.
- FDA Inspection 830063 - 2013-05-03
- FDA Inspection 826651 - 2013-04-09
- FDA Inspection 629926 - 2009-11-10
- FDA Inspection 560475 - 2009-01-21
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