FDA Inspection
Janssen Biotech, Inc.Janssen Biotech, Inc. – FDA Inspection, Nov 21, 2017
Record Details
This FDA Inspection record concerns Janssen Biotech, Inc., with an inspection on November 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Marcelo O. Mangalindan (Issuing Officer)
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ID · 2f697eb7-fa9a-4da8-b845-2d83b13b09f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031776
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 312.56(b)Investigator non-compliance
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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 |
| March 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1046499 - 2018-03-05
- FDA Inspection 1027122 - 2017-09-22
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