Warning letter
Biotronik, Inc.: warning letter of Jun 4, 2004
FDA warning letter UCM146857 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM146857 |
|---|---|
| Company | Biotronik, Inc. |
| Subject | Sponsor Obligations |
| Issue date | Jun 4, 2004 |
| Posted date | Jun 4, 2004 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.40, 812.46, 812.145, 812, 812.46(a), 820, 812.140(e) |
| Country | 3 |
| Inspection city | Lake Oswego |
| Inspection ZIP | 97035-5571 |
| Inspection start date | Dec 16, 2003 |
| 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: