Warning letter
Roth International Ltd.: warning letter of Oct 15, 2001
FDA warning letter UCM178324 · Chicago District Office
Key facts
| Reference number | UCM178324 |
|---|---|
| Company | Roth International Ltd. |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Oct 15, 2001 |
| Posted date | Oct 15, 2001 |
| Issuing office | Chicago District Office |
| Product type | Devices |
| CFR sections cited | 211, 820 |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: