Drug factory · FDA FEI 2243819
AIM ImmunoTech Inc.
North Brunswick, New Jersey, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
No problems found at FDA's last inspection, Jan 5, 2017.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2010: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Interferon Alfa-N3 | Makes the active ingredient | AIM ImmunoTech Inc | 54746-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 5, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 9, 2012 | Problems found, fixed voluntarily | Bioresearch Monitoring | 5 |
| Jun 22, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 9, 2012 inspection
- General responsibilities of sponsors 21 CFR 312.50
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan. - Transfer of obligations 21 CFR 312.52(a)
Transfer of obligations to a contract research organization did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed. - Shipment to unauthorized persons 21 CFR 312.53(b)
Shipment of an investigational new drug to someone not an investigator participating in the investigation. - Investigator non-compliance 21 CFR 312.56(b)
An investigator who did not comply with the signed agreement was not promptly brought into compliance. - Records of Financial Interests 21 CFR 312.57(b)
Failure to maintain complete records of disclosable financial interests paid to clinical investigators by the sponsor.