Warning letter
Boston Scientific Corporation: warning letter of Jan 25, 2006
FDA warning letter UCM075775 · New England District Office
Key facts
| Reference number | UCM075775 |
|---|---|
| Company | Boston Scientific Corporation |
| Subject | CGMP for Medical Devices/Medical Device Reporting/Misbranded |
| Issue date | Jan 25, 2006 |
| Posted date | Jan 25, 2006 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 806.10(a)(1), 803, 806, 803.50(a)(1), 803.50(a)(2), 820 |
| Country | 3 |
| Inspection city | Quincy |
| Inspection ZIP | 02171-1518 |
| Inspection start date | Jul 27, 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: