FDA Inspection
Janssen - Cilag Spa.Janssen - Cilag Spa. – FDA Inspection, Sep 11, 2014
Record Details
This FDA Inspection record concerns Janssen - Cilag Spa., with an inspection on September 11, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Janssen - Cilag Spa.
- Inspection Date
- September 11, 2014
- Product Type
- Drugs
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ID · df2fd984-efc7-437a-98b6-657654084a79
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900655
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Janssen - Cilag Spa.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2019 | Not classified | Office of Inspections and Investigations | |
| May 18, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Janssen - Cilag Spa.
- FDA Inspection 1202704 - 2022-01-27
- FDA Inspection 1079878 - 2019-01-25
- FDA Inspection 1092778 - 2018-05-18
- FDA Inspection 981327 - 2016-04-29
- FDA Inspection 697700 - 2010-10-21
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