Warning letter
Wintech Medipro LLC: warning letter of Nov 16, 2022
FDA warning letter 640048 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 640048 |
|---|---|
| Company | Wintech Medipro LLC |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated |
| Issue date | Nov 16, 2022 |
| Posted date | Feb 14, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 878.4040, 820, 807.81(b) |
| Inspection city | Katy |
| Inspection ZIP | 77449 |
| Inspection start date | Jun 22, 2022 |
| Letter on fda.gov | fda.gov |
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: