FDA Inspection
Akers Biosciences, Inc.Akers Biosciences, Inc. – FDA Inspection, Apr 11, 2012
Record Details
This FDA Inspection record concerns Akers Biosciences, Inc., with an inspection on April 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Akers Biosciences, Inc.
- Inspection Date
- April 11, 2012
- Product Type
- Devices
View Company Profile
ID · 0f55fa62-46d4-4020-a742-ce51120417d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775226
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of Akers Biosciences, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Akers Biosciences, Inc.
- FDA Inspection 947128 - 2015-11-04
- FDA Inspection 721635 - 2011-05-09
- FDA Inspection 571594 - 2009-04-09
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