FDA Inspection
ONC Solutions IncorporatedONC Solutions Incorporated – FDA Inspection, Jun 27, 2013
Record Details
This FDA Inspection record concerns ONC Solutions Incorporated, with an inspection on June 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ONC Solutions Incorporated
- Inspection Date
- June 27, 2013
- Product Type
- Devices
View Company Profile
ID · e5d58134-3df2-4963-b70c-e03adb1c0ff8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838358
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ONC Solutions Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 24, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 23, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ONC Solutions Incorporated
- FDA Inspection 1101649 - 2019-09-10
- FDA Inspection 678309 - 2010-08-24
- FDA Inspection 571626 - 2009-03-23
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