Company
United StatesAkers Biosciences, Inc., Thorofare, NJ – FDA Inspections
Inspection records and compliance data for Akers Biosciences, Inc. in Thorofare, New Jersey. 4 FDA inspections on record (1 OAI), last inspected November 04, 2015.
Company Profile
This profile covers Akers Biosciences, Inc. based in Thorofare, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 9, 2009. Last inspected November 4, 2015.
Most cited issue areas
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Lack of or inadequate process validation1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 4, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 947128 |
| April 11, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 775226 |
| May 9, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 721635 |
| April 9, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 571594 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Akers Biosciences, Inc.
FEI Number
1000121922
Address
201 Grove Rd, Thorofare, New Jersey 08086, United States
Country
United States
ID: 7b4b3cb6-85c7-4ba0-902f-159285611680