FDA Inspection
Diamedix CorporationDiamedix Corporation – FDA Inspection, Mar 17, 2016
Record Details
This FDA Inspection record concerns Diamedix Corporation, with an inspection on March 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diamedix Corporation
- Inspection Date
- March 17, 2016
- Product Type
- Devices
View Company Profile
ID · 5ab07d42-0c65-4b57-a11e-30a080a833bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969986
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diamedix Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Diamedix Corporation
- FDA Inspection 605567 - 2009-08-18
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