FDA Inspection
Janssen Cilag Manufacturing LLCJanssen Cilag Manufacturing LLC – FDA Inspection, Feb 11, 2026
Record Details
This FDA Inspection record concerns Janssen Cilag Manufacturing LLC, with an inspection on February 11, 2026, issued by the San Juan District Office, covering human drugs.
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ID · 34b6f379-9ab6-4b7e-ac2f-863b12eda16c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302416
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Janssen Cilag Manufacturing LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 23, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 13, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 23, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Janssen Cilag Manufacturing LLC
- FDA Inspection 1158642 - 2021-11-23
- FDA Inspection 1029739 - 2017-08-07
- FDA Inspection 998481 - 2017-01-13
- FDA Inspection 872370 - 2014-02-24
- FDA Inspection 854433 - 2013-10-23
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