FDA Inspection
Oncology Data Systems, Inc.Oncology Data Systems, Inc. – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns Oncology Data Systems, Inc., with an inspection on December 11, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oncology Data Systems, Inc.
- Inspection Date
- December 11, 2008
- Product Type
- Devices
View Company Profile
ID · b0254394-e9c9-4807-a656-795b75a6b331
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 552060
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(d)(3)No release signature
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(c)Design input approval documentation
- 21 CFR 820.30(d)Design output - review and approval
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oncology Data Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Oncology Data Systems, Inc.
- FDA Inspection 952581 - 2015-11-05
- FDA Inspection 759881 - 2011-12-21
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