FDA Inspection
Janssen Ortho LLCJanssen Ortho LLC – FDA Inspection, Aug 28, 2018
Record Details
This FDA Inspection record concerns Janssen Ortho LLC, with an inspection on August 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4c91b92d-4597-4c58-9e17-38de8ee2a589
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063744
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Janssen Ortho LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | San Juan District Office | Drug Quality Assurance |
| March 28, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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