FDA Inspection
Janssen Ortho LLCJanssen Ortho LLC – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Janssen Ortho LLC, with an inspection on May 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 17770b44-9e8e-4aec-baff-f13a6ae5f3dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012089
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| August 28, 2018 | 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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