Warning letter
Biotronik, Inc.: warning letter of Jul 14, 2003
FDA warning letter UCM147583 · Seattle District Office
Key facts
| Reference number | UCM147583 |
|---|---|
| Company | Biotronik, Inc. |
| Subject | Medical Devices Reports of Correction & Removals |
| Issue date | Jul 14, 2003 |
| Posted date | Jul 14, 2003 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.2(i), 806.10(a)(1), 806.10, 7.3(m) |
| Country | 3 |
| Inspection city | Lake Oswego |
| Inspection ZIP | 97035-5571 |
| Inspection start date | Apr 8, 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: