FDA Inspection
Atossa Genetics, Inc.Atossa Genetics, Inc. – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns Atossa Genetics, Inc., with an inspection on March 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atossa Genetics, Inc.
- Inspection Date
- March 14, 2014
- Product Type
- Devices
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ID · bf1acbc7-ca7a-4f4b-a1a1-ac1a495b9ce2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 870293
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Atossa Genetics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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