Warning letter
Lion Street Medical, d/b/a Pensar Medical LLC: warning letter of Aug 21, 2026
FDA warning letter 733015 · Center for Devices and Radiological Health
Key facts
| Reference number | 733015 |
|---|---|
| Company | Lion Street Medical, d/b/a Pensar Medical LLC |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Aug 21, 2026 |
| Posted date | Sep 22, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3(m)(2), 803.3(w), 803.17, 803.17(a)(1), 803.17(b), 803.18(b)(1)(i), 803.20(c)(1), 803.50(a)(1), 806, 806.10, 803.50(a) and 2 more |
| Inspection city | Houston |
| Inspection ZIP | 77024 |
| Inspection start date | Apr 14, 2026 |
| 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: