FDA Inspection
Janssen Pharmaceutica NVJanssen Pharmaceutica NV – FDA Inspection, May 16, 2014
Record Details
This FDA Inspection record concerns Janssen Pharmaceutica NV, with an inspection on May 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Janssen Pharmaceutica NV
- Inspection Date
- May 16, 2014
- Product Type
- Drugs
View Company Profile
ID · 9d4cfe05-92ac-4dfa-b9ac-7ac0a5b71815
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878913
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.160(a)Deviations from laboratory control requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Janssen Pharmaceutica NV
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2025 | Not classified | Office of Inspections and Investigations | |
| February 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Janssen Pharmaceutica NV
- FDA Inspection 1302316 - 2025-10-07
- FDA Inspection 1220158 - 2021-02-03
- FDA Inspection 785854 - 2012-05-10
- FDA Inspection 591562 - 2009-06-08
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