FDA Inspection
Numed IncNumed Inc – FDA Inspection, Apr 29, 2016
Record Details
This FDA Inspection record concerns Numed Inc, with an inspection on April 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Numed Inc
- Inspection Date
- April 29, 2016
- Product Type
- Devices
View Company Profile
ID · 51335b74-03a1-4c80-b17c-4b741674bf84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988504
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Numed Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 5, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Numed Inc
- FDA Inspection 1008050 - 2017-04-13
- FDA Inspection 900633 - 2014-10-10
- FDA Inspection 796615 - 2012-08-23
- FDA Inspection 668397 - 2010-06-10
- FDA Inspection 620405 - 2009-10-05
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