FDA Inspection
Mindray DS USA, Inc. dba Mindray North AmericaFDA Inspection 668336 - Mindray DS USA, Inc. dba Mindray North America - June 10, 2010
Record Details
This FDA Inspection record concerns Mindray DS USA, Inc. dba Mindray North America, with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 10, 2010
- Product Type
- Devices
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ID · b61a2a8d-7bf6-4c2b-89b6-78c858d5e6c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 668336
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mindray DS USA, Inc. dba Mindray North America
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 31, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mindray DS USA, Inc. dba Mindray North America
- FDA Inspection 1251239 - 2024-02-22
- FDA Inspection 1062457 - 2018-04-20
- FDA Inspection 968103 - 2016-03-31
- FDA Inspection 910764 - 2015-03-10
- FDA Inspection 849828 - 2013-09-23
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