Warning letter
St Jude Medical, Inc.: warning letter of Mar 17, 2005
FDA warning letter UCM075328 · San Juan District Office
Key facts
| Reference number | UCM075328 |
|---|---|
| Company | St Jude Medical, Inc. |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Mar 17, 2005 |
| Posted date | Mar 17, 2005 |
| Issuing office | San Juan District Office |
| Product type | Devices |
| Country | 3 |
| Inspection city | Caguas |
| Inspection ZIP | 00725 |
| Inspection start date | Sep 27, 2004 |
| Letter on fda.gov | web.archive.org |
At a glance
- 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: