Warning letter
North American Vaccine Inc.: warning letter of Oct 8, 1999
FDA warning letter UCM067760 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM067760 |
|---|---|
| Company | North American Vaccine Inc. |
| Subject | Production process Controls/Failure to Report Changes to Application |
| Issue date | Oct 8, 1999 |
| Posted date | Oct 8, 1999 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 21, 211, 211.67, 211.100, 211.110, 211.160, 211.166, 211.192, 601.12(a), 211.160(b) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
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: