FDA Inspection
IVD Research, Inc.IVD Research, Inc. – FDA Inspection, Oct 9, 2008
Record Details
This FDA Inspection record concerns IVD Research, Inc., with an inspection on October 9, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- IVD Research, Inc.
- Inspection Date
- October 9, 2008
- Product Type
- Devices
View Company Profile
ID · a0ea2d87-c32b-4e50-a8b2-fa40658ab916
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 538654
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
16- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
Showing 10 of 16 citations.
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Other FDA inspections of IVD Research, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | Not classified | Los Angeles District Office | |
| September 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for IVD Research, Inc.
- FDA Inspection 1279667 - 2025-08-07
- FDA Inspection 943186 - 2015-09-18
- FDA Inspection 728076 - 2011-05-31
- FDA Inspection 628913 - 2009-11-10
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