Warning letter
CRS Medical Diagnostics, Inc.: warning letter of Mar 21, 2008
FDA warning letter UCM1048364 · Minneapolis District Office
Key facts
| Reference number | UCM1048364 |
|---|---|
| Company | CRS Medical Diagnostics, Inc. |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Mar 21, 2008 |
| Posted date | Mar 21, 2008 |
| Issuing office | Minneapolis District Office |
| Product type | Devices |
| CFR sections cited | 807.97, 820, 820.40 |
| Country | 3 |
| Inspection city | New Berlin |
| Inspection ZIP | 53151-5234 |
| Inspection start date | Dec 17, 2007 |
| 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: