Warning letter
Texas Orthopaedic Products & Services, LLC: warning letter of Apr 12, 2004
FDA warning letter UCM146336 · Dallas District Office
Key facts
| Reference number | UCM146336 |
|---|---|
| Company | Texas Orthopaedic Products & Services, LLC |
| Subject | QSR/Lacks Approved Premarket Application/Misbranded/Adulterated |
| Issue date | Apr 12, 2004 |
| Posted date | Apr 12, 2004 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Country | 3 |
| Inspection city | Rockwall |
| Inspection ZIP | 75087-2193 |
| Inspection start date | Nov 13, 2003 |
| 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: