FDA Inspection
Janssen Ortho LLCJanssen Ortho LLC – FDA Inspection, May 29, 2015
Record Details
This FDA Inspection record concerns Janssen Ortho LLC, with an inspection on May 29, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Janssen Ortho LLC
- Inspection Date
- May 29, 2015
- Product Type
- Drugs
View Company Profile
ID · ca7c6639-39bb-4542-b106-9817ad3e550b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930456
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.134(c)Examinations 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 26, 2017 | 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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