FDA Inspection
Janssen Biotech, Inc.Janssen Biotech, Inc. – FDA Inspection, Mar 5, 2018
Record Details
This FDA Inspection record concerns Janssen Biotech, Inc., with an inspection on March 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4135886d-b271-492a-8b05-81d78eba721b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046499
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Janssen Biotech, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2025 | Not classified | Philadelphia District Office | |
| March 10, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 30, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 21, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 22, 2017 | Not classified | Philadelphia District Office |
Other documents for Janssen Biotech, Inc.
- FDA Inspection 1276933 - 2025-07-29
- FDA Inspection 1265723 - 2025-03-10
- FDA Inspection 1077487 - 2018-11-30
- FDA Inspection 1031776 - 2017-11-21
- FDA Inspection 1027122 - 2017-09-22
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