Jazz Pharmaceuticals, Inc.
Form 483 issued May 6, 2011 · Palo Alto, California
- Inspection
- Apr 27 – May 6, 2011
- Investigator
- Daniel J. Roberts
- Observations
- 3
- Pages
- 4
- FEI number
- 3005615655
In short: On May 6, 2011, FDA issued a Form 483 with 3 observations to Jazz Pharmaceuticals, Inc. in Palo Alto, California (FEI 3005615655) after an inspection that ran Apr 27 – May 6, 2011. The investigator was Daniel J. Roberts. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of…
- 03
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJazz Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(c)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jazz Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Jazz Pharmaceuticals, Inc.?
Daniel J. Roberts is named on this Form 483, for the inspection of Apr 27 – May 6, 2011. Each investigator has a profile showing what they cite most.
When was Jazz Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Apr 27 – May 6, 2011, and the Form 483 is dated May 6, 2011.
How do I get the full Form 483 for Jazz Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.