Unimicro Medical Systems (Shenzhen) Co., Ltd.
FDA establishment 3010806467, Shenzhen, China. Part of Unimicro Medical Systems (Shenzhen) Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
- Inspections: 2
- Official action indicated: 0
- Last inspection ended: Mar 3, 2023
- Warning letters: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
Inspections
2 inspections, newest first| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Mar 3, 2023 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Nov 9, 2017 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
Warning Letters
Letters naming this establishment; each opens the letter- Medical DevicesMay 18, 2023
- Sterility assurance, Process validation, CAPAJan 6, 2022
Identifiers
- FEI number
- 3010806467
- FDA firm profile
- Data Dashboard
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters