Warning letter
HemoSense Corporation: warning letter of Oct 4, 2005
FDA warning letter UCM075594 · San Francisco District Office
Key facts
| Reference number | UCM075594 |
|---|---|
| Company | HemoSense Corporation |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Oct 4, 2005 |
| Posted date | Oct 4, 2005 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 803.17, 803.50, 803.50(a), 803, 803.3, 803.50(a)(1) |
| Country | 3 |
| Inspection city | San Diego |
| Inspection ZIP | 92121-2997 |
| Inspection start date | May 16, 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: