Warning letter
Organon USA Inc.: warning letter of Sep 29, 2003
FDA warning letter UCM147745 · New Jersey District Office
Key facts
| Reference number | UCM147745 |
|---|---|
| Company | Organon USA Inc. |
| Subject | GMP Finished Pharmaceuticals/Postmarketing/Reporting Adverse Drug Experiences/Adulterated |
| Issue date | Sep 29, 2003 |
| Posted date | Sep 29, 2003 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.65, 211.160, 211.192, 314.80 |
| Country | 3 |
| Inspection city | West Orange |
| Inspection ZIP | 07052-2724 |
| Inspection start date | Apr 24, 2003 |
| 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: