FDA Inspection
Janssen Biotech, Inc.Janssen Biotech, Inc. – FDA Inspection, Oct 26, 2010
Record Details
This FDA Inspection record concerns Janssen Biotech, Inc., with an inspection on October 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Janssen Biotech, Inc.
- Inspection Date
- October 26, 2010
- Product Type
- Drugs
View Company Profile
ID · 537c661b-815e-4e81-b95f-2f837704182d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685099
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 312.50General responsibilities of sponsors
Full citation text and observation details available on the Dashboard.
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 |
| November 21, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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 1031776 - 2017-11-21
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