FDA Inspection
Mindray DS USA, Inc. dba Mindray North AmericaFDA Inspection 795266 - Mindray DS USA, Inc. dba Mindray North America - August 02, 2012
Record Details
This FDA Inspection record concerns Mindray DS USA, Inc. dba Mindray North America, with an inspection on August 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 2, 2012
- Product Type
- Devices
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ID · 693c2780-29f2-4130-927a-011bf9532650
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 795266
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
- 21 CFR 820.30(g)Design validation - software validation not performed
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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