FDA Inspection
Janssen Cilag Manufacturing LLCJanssen Cilag Manufacturing LLC – FDA Inspection, Aug 7, 2017
Record Details
This FDA Inspection record concerns Janssen Cilag Manufacturing LLC, with an inspection on August 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7736c42b-93d1-4ea7-a7f5-c8f17755831d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029739
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Janssen Cilag Manufacturing LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2026 | VAI | San Juan District Office | Drug Quality Assurance |
| November 23, 2021 | 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 1302416 - 2026-02-11
- FDA Inspection 1158642 - 2021-11-23
- FDA Inspection 998481 - 2017-01-13
- FDA Inspection 872370 - 2014-02-24
- FDA Inspection 854433 - 2013-10-23
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