FDA Inspection
Janssen Pharmaceuticals, IncJanssen Pharmaceuticals, Inc – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Janssen Pharmaceuticals, Inc, with an inspection on September 25, 2026, issued by the New Jersey District Office, covering human drugs.
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ID · 16fafd4a-7311-420b-b8bd-7c82af1e2eb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1338168
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- FDCA 505-1(f)(3)(D)Failure to comply with REMS Elements to Assure Safe Use (ETASU) D
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Other FDA inspections of Janssen Pharmaceuticals, Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2025 | Not classified | New Jersey District Office | |
| September 27, 2024 | NAI | New Jersey District Office | Bioresearch Monitoring: Human Drugs |
| 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 1271223 - 2025-08-14
- FDA Inspection 1229931 - 2024-09-27
- FDA Inspection 1131617 - 2020-09-28
- FDA Inspection 1131381 - 2020-09-14
- FDA Inspection 1031605 - 2017-10-06
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