Warning letter
Boston Scientific Corporation: warning letter of Aug 10, 2005
FDA warning letter UCM075514 · New England District Office
Key facts
| Reference number | UCM075514 |
|---|---|
| Company | Boston Scientific Corporation |
| Subject | Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated |
| Issue date | Aug 10, 2005 |
| Posted date | Aug 10, 2005 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 806, 820, 820.1, 820.40 |
| Country | 3 |
| Inspection city | Quincy |
| Inspection ZIP | 02171-1518 |
| Inspection start date | Mar 28, 2005 |
| 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: