FDA Inspection 807004 — AIM ImmunoTech Inc
The FDA completed an inspection of AIM ImmunoTech Inc on November 9, 2012 in North Brunswick, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- North Brunswick, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7409 | 21 CFR 312.53(b) | Shipment to unauthorized persons |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7458 | 21 CFR 312.57(b) | Records of Financial Interests |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |