Warning letter
Cardinal Enterprises, Inc.: warning letter of Dec 7, 2001
FDA warning letter UCM178608 · New England District Office
Key facts
| Reference number | UCM178608 |
|---|---|
| Company | Cardinal Enterprises, Inc. |
| Subject | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 7, 2001 |
| Posted date | Dec 7, 2001 |
| Issuing office | New England District Office |
| Product type | Drugs |
| CFR sections cited | 21, 211.25, 211.103, 211.113, 211.137, 211.42(c)(7), 211.84(d), 211.100(b), 211.130(d), 211.134(c), 211.125, 211.188(b) |
| Country | 3 |
| Inspection city | Middletown |
| Inspection ZIP | 02842-7629 |
| Inspection start date | Oct 16, 2001 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: