FDA Inspection
Atossa Genetics, Inc.Atossa Genetics, Inc. – FDA Inspection, Jul 25, 2012
Record Details
This FDA Inspection record concerns Atossa Genetics, Inc., with an inspection on July 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atossa Genetics, Inc.
- Inspection Date
- July 25, 2012
- Product Type
- Devices
View Company Profile
ID · e4026a9d-8a21-450c-9400-dd56e1b34f04
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 792746
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Atossa Genetics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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