Warning letter
Eagle Diagnostics, Inc.: warning letter of Oct 10, 2002
FDA warning letter UCM145166 · Dallas District Office
Key facts
| Reference number | UCM145166 |
|---|---|
| Company | Eagle Diagnostics, Inc. |
| Subject | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| Issue date | Oct 10, 2002 |
| Posted date | Oct 10, 2002 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 807.20, 820 |
| Country | 3 |
| Inspection city | Cedar Hill |
| Inspection ZIP | 75104-2555 |
| Inspection start date | Apr 8, 2002 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: