FDA Inspection
Janssen Pharmaceuticals, IncJanssen Pharmaceuticals, Inc – FDA Inspection, Sep 27, 2024
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, Inc, with an inspection on September 27, 2024, issued by the New Jersey District Office, covering human drugs.
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ID · a957db33-ff2d-4e98-86e3-9332d9d2d54b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1229931
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring: Human Drugs
FDA Citations
2- Failure to comply with REMS Implementation System
- FDCA 505-1(f)(4)Failure to comply with REMS Implementation System
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Other FDA inspections of Janssen Pharmaceuticals, Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | VAI | New Jersey District Office | Postmarket Surv. and Epidemiology |
| August 14, 2025 | Not classified | New Jersey District Office | |
| September 28, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Janssen Pharmaceuticals, Inc
- FDA Inspection 1338168 - 2026-09-25
- FDA Inspection 1271223 - 2025-08-14
- FDA Inspection 1131617 - 2020-09-28
- FDA Inspection 1131381 - 2020-09-14
- FDA Inspection 1031605 - 2017-10-06
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