Warning letter
Uroplasty, Inc.: warning letter of Jul 19, 2005
FDA warning letter UCM075490 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM075490 |
|---|---|
| Company | Uroplasty, Inc. |
| Subject | Sponsor Obligations |
| Issue date | Jul 19, 2005 |
| Posted date | Jul 19, 2005 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.43(c), 812.43(c)(5), 814.20(b)(6)(ii), 50, 812.40, 812, 812.46(a) |
| Country | 3 |
| Inspection city | Minnetonka |
| Inspection ZIP | 55343-7982 |
| Inspection start date | Mar 8, 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: