Warning letter
Red Oak Instruments, LLC: warning letter of Feb 21, 2025
FDA warning letter 692368 · Center for Devices and Radiological Health
Key facts
| Reference number | 692368 |
|---|---|
| Company | Red Oak Instruments, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Feb 21, 2025 |
| Posted date | Mar 18, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 886.9(a), 820, 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.18(b)(1)(i), 803.50(a), 807.81(a)(3)(ii) and 2 more |
| Inspection city | Missouri City |
| Inspection ZIP | 77459 |
| Inspection start date | Jul 15, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: