Warning letter
Unimicro Medical Systems-Shenzhen Co., Ltd.: warning letter of Jan 6, 2022
FDA warning letter 624560 · Center for Devices and Radiological Health
Key facts
| Reference number | 624560 |
|---|---|
| Company | Unimicro Medical Systems-Shenzhen Co., Ltd. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 6, 2022 |
| Posted date | Mar 22, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Shenzhen |
| Inspection start date | Sep 15, 2021 |
| 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: