FDA Inspection 571594 — Akers Biosciences, Inc.
The FDA completed an inspection of Akers Biosciences, Inc. on April 9, 2009 in Thorofare, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Thorofare, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4189 | 21 CFR 820.198(a) | General |