Jazz Pharmaceuticals, Inc.
FDA inspection history in Palo Alto, California, 2011
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2011: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter and one Form 483, at Palo Alto, California.
Cited most
Across all Jazz Pharmaceuticals observations on file
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences3
The complete Jazz Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Palo Alto, California
One warning letter and one Form 483 · 2011 · 3 observations
Latest: Warning letter, Oct 11, 2011 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2011-10-11 | Warning letter Warning letter | Palo Alto, California | — | $99 |
| 2011-05-06 | 483 Form 483 | Palo Alto, California | 3 | $99 |
Investigators on these documents
FEI number 3005615655 · most recent document Oct 11, 2011
About Jazz Pharmaceuticals, Inc.
How many FDA Form 483s has Jazz Pharmaceuticals, Inc. received?
FDA Intel has 1 Form 483 on file for Jazz Pharmaceuticals, Inc.; the most recent is dated May 6, 2011.
When was Jazz Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Jazz Pharmaceuticals, Inc. is a Form 483 dated May 6, 2011, for the site in Palo Alto, California.
What did FDA cite at Jazz Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Jazz Pharmaceuticals, Inc. are 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 3 times.
Has Jazz Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Jazz Pharmaceuticals, Inc.; the most recent is dated Oct 11, 2011.