FDA Inspection
NUCMEDCOR (NH), LLCNUCMEDCOR (NH), LLC – FDA Inspection, May 11, 2011
Record Details
This FDA Inspection record concerns NUCMEDCOR (NH), LLC, with an inspection on May 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NUCMEDCOR (NH), LLC
- Inspection Date
- May 11, 2011
- Product Type
- Devices
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ID · cf025ddc-e781-42c4-8152-ab4d741018f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723996
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of NUCMEDCOR (NH), LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NUCMEDCOR (NH), LLC
- FDA Inspection 1081747 - 2019-02-27
- FDA Inspection 940286 - 2015-08-07
- FDA Inspection 832368 - 2013-05-21
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