FDA Inspection
Diomedics, Inc.Diomedics, Inc. – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Diomedics, Inc., with an inspection on May 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6e672ca1-2df6-43b2-9dfa-d4a55782cdb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017180
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Diomedics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 15, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Diomedics, Inc.
- FDA Inspection 806234 - 2012-11-06
- FDA Inspection 575786 - 2009-04-15
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