FDA Inspection
Clinical Innovations, LLCClinical Innovations, LLC – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns Clinical Innovations, LLC, with an inspection on March 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d946537-eca9-4a56-ab36-4385ff5186f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082768
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Clinical Innovations, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 27, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Clinical Innovations, LLC
- FDA Inspection 831149 - 2013-05-08
- FDA Inspection 661326 - 2010-04-27
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