Warning letter
Express Diagnostics Int'l., Inc [ARCHIVED]: warning letter of Mar 12, 2009
FDA warning letter 49679 · Minneapolis District Office
Key facts
| Reference number | 49679 |
|---|---|
| Company | Express Diagnostics Int'l., Inc [ARCHIVED] |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Mar 12, 2009 |
| Posted date | Mar 12, 2009 |
| Issuing office | Minneapolis District Office |
| Product type | Devices |
| CFR sections cited | 21, 807.81(a)(3)(i), 807.85(b), 807.81(b) |
| Inspection city | Blue Earth |
| Inspection ZIP | 56013 |
| Inspection start date | Oct 28, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: