FDA Inspection
Janssen Ortho LLCJanssen Ortho LLC – FDA Inspection, Jun 5, 2026
Record Details
This FDA Inspection record concerns Janssen Ortho LLC, with an inspection on June 5, 2026, issued by the San Juan District Office, covering human drugs.
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ID · 67acf1a5-b858-4c2c-bb88-e0ac0e3818da
Inspection Facts
- Inspection number
- 1320870
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Janssen Ortho LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 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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