FDA Inspection
Diamond Diagnostics, Inc.Diamond Diagnostics, Inc. – FDA Inspection, Jul 2, 2009
Record Details
This FDA Inspection record concerns Diamond Diagnostics, Inc., with an inspection on July 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diamond Diagnostics, Inc.
- Inspection Date
- July 2, 2009
- Product Type
- Devices
View Company Profile
ID · 0af29d79-80b6-4d87-b368-41431a9b60f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594561
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.70(a)(1)Process control instructions
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diamond Diagnostics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 23, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Diamond Diagnostics, Inc.
- FDA Inspection 1208306 - 2023-06-08
- FDA Inspection 1001721 - 2017-02-16
- FDA Inspection 853836 - 2013-10-23
- FDA Inspection 737193 - 2011-08-04
- FDA Inspection 663279 - 2010-05-25
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