Warning letter
Warner Chilcott, Inc: warning letter of Mar 18, 2003
FDA warning letter UCM147372 · New Jersey District Office
Key facts
| Reference number | UCM147372 |
|---|---|
| Company | Warner Chilcott, Inc |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Mar 18, 2003 |
| Posted date | Mar 18, 2003 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 314.80, 314.80(c), 314.80(b) |
| Country | 3 |
| Inspection city | Rockaway |
| Inspection ZIP | 07866-2116 |
| Inspection start date | Oct 7, 2002 |
| 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: