FDA Inspection 1060763 — Immunomedics, Inc.
The FDA completed an inspection of Immunomedics, Inc. on Aug 1, 2018 in Morris Plains, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Morris Plains, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7483 | 21 CFR 312.55(b) | New observations, adverse effects and risks |
| 7632 | 21 CFR 312.6(a) | Required label statement |