Warning letter
Actavis Totowa, LLC: warning letter of Aug 15, 2006
FDA warning letter UCM076033 · New Jersey District Office
Key facts
| Reference number | UCM076033 |
|---|---|
| Company | Actavis Totowa, LLC |
| Subject | Postmarketing Adverse Drug Experience (ADE) Reporting |
| Issue date | Aug 15, 2006 |
| Posted date | Aug 15, 2006 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 310.305, 314.80, 314.98, 314.80(c)(1)(ii), 314.80(b), 314.80(c)(2), 314.80(d) |
| Country | 3 |
| Inspection city | Little Falls |
| Inspection ZIP | 07424-5608 |
| Inspection start date | Jan 10, 2006 |
| 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: