FDA Inspection
ONC Solutions IncorporatedONC Solutions Incorporated – FDA Inspection, Sep 10, 2019
Record Details
This FDA Inspection record concerns ONC Solutions Incorporated, with an inspection on September 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 950fb5e2-7708-4624-94a2-17ad4340b2f2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1101649
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ONC Solutions Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2013 | VAI | Center for Devices and Radiological Health | Compliance: 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 838358 - 2013-06-27
- FDA Inspection 678309 - 2010-08-24
- FDA Inspection 571626 - 2009-03-23
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