FDA Inspection 1225275 — Janssen Pharmaceuticals Inc.
The FDA completed an inspection of Janssen Pharmaceuticals Inc. on Dec 14, 2023 in Raritan, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Raritan, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |