FDA Inspection
Stellar Medical LLC.Stellar Medical LLC. – FDA Inspection, Feb 14, 2013
Record Details
This FDA Inspection record concerns Stellar Medical LLC., with an inspection on February 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stellar Medical LLC.
- Inspection Date
- February 14, 2013
- Product Type
- Devices
View Company Profile
ID · ff3a5b7b-b9e8-48aa-9fc2-467f40102826
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818922
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Stellar Medical LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stellar Medical LLC.
- FDA Inspection 891591 - 2014-07-11
- FDA Inspection 788024 - 2012-06-27
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