FDA Inspection
Mindray DS USA, Inc. dba Mindray North AmericaFDA Inspection 968103 - Mindray DS USA, Inc. dba Mindray North America - March 31, 2016
Record Details
This FDA Inspection record concerns Mindray DS USA, Inc. dba Mindray North America, with an inspection on March 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 31, 2016
- Product Type
- Devices
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ID · 2b9c3d57-be90-4c86-a345-418e4d9f795a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 968103
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.198(c)Investigation of device failures
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 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2012 | OAI | 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 910764 - 2015-03-10
- FDA Inspection 849828 - 2013-09-23
- FDA Inspection 795266 - 2012-08-02
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