FDA Inspection
ONC Solutions IncorporatedONC Solutions Incorporated – FDA Inspection, Aug 24, 2010
Record Details
This FDA Inspection record concerns ONC Solutions Incorporated, with an inspection on August 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ONC Solutions Incorporated
- Inspection Date
- August 24, 2010
- Product Type
- Devices
View Company Profile
ID · ecdac553-87f2-4125-adc7-99c276a9d0b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678309
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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 |
| June 27, 2013 | 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 838358 - 2013-06-27
- FDA Inspection 571626 - 2009-03-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.