Warning letter
GlaxoSmithKline: warning letter of Mar 25, 2008
FDA warning letter UCM1048360 · Atlanta District Office
Key facts
| Reference number | UCM1048360 |
|---|---|
| Company | GlaxoSmithKline |
| Subject | Postmarketing Adverse Drug Experience |
| Issue date | Mar 25, 2008 |
| Posted date | Mar 25, 2008 |
| Issuing office | Atlanta District Office |
| Product type | Drugs |
| CFR sections cited | 314.80(c)(2)(ii), 314.81(b)(2)(viii), 314.81(b)(2)(vii) |
| Country | 3 |
| Inspection city | Research Triangle Park |
| Inspection ZIP | 27709 |
| Inspection start date | Aug 20, 2007 |
| 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: