Warning letter
Jazz Pharmaceuticals, Inc [ARCHIVED]: warning letter of Oct 11, 2011
FDA warning letter 192992 · San Francisco District Office
Key facts
| Reference number | 192992 |
|---|---|
| Company | Jazz Pharmaceuticals, Inc [ARCHIVED] |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Oct 11, 2011 |
| Posted date | Oct 11, 2011 |
| Issuing office | San Francisco District Office |
| Product type | Drugs |
| CFR sections cited | 314.80(c)(1)(i), 314.80, 314.80(c)(1)(ii), 314.80(b) |
| Inspection city | Palo Alto |
| Inspection ZIP | 94304 |
| Inspection start date | Apr 27, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: