FDA Inspection
Jazz Pharmaceuticals, IncJazz Pharmaceuticals, Inc – FDA Inspection, Jun 10, 2019
Record Details
This FDA Inspection record concerns Jazz Pharmaceuticals, Inc, with an inspection on June 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ff75c03d-fad2-4ff1-8786-cdec2ed6f766
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094205
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
3- FDCA 505-1(f)(3)(B)Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(j)Failure to maintain records
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Other FDA inspections of Jazz Pharmaceuticals, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2017 | Not classified | San Francisco District Office | |
| July 20, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 4, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 30, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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