Warning letter
Louisville APL Diagnostics, Inc.: warning letter of Jul 18, 2007
FDA warning letter UCM076449 · Dallas District Office
Key facts
| Reference number | UCM076449 |
|---|---|
| Company | Louisville APL Diagnostics, Inc. |
| Subject | Device/Adulterated |
| Issue date | Jul 18, 2007 |
| Posted date | Jul 18, 2007 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.2(i), 806.10(a)(1), 806.20(b)(4), 820 |
| Country | 3 |
| Inspection city | Texas City |
| Inspection ZIP | 77590-7451 |
| Inspection start date | Apr 24, 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: