FDA Inspection 664631 — Imclone Systems
The FDA completed an inspection of Imclone Systems on May 21, 2010 in Bridgewater, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 21, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bridgewater, NJ (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7452 | 21 CFR 312.56(c) | IND safety report |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7629 | 21 CFR 312.56(c) | Annual report |