Mindray DS USA, Inc. dba Mindray North America - Inspection Records
Inspection records and compliance data for Mindray DS USA, Inc. dba Mindray North America in Mahwah, New Jersey. 7 FDA inspections on record (2 OAI), last inspected February 22, 2024.
This profile covers Mindray DS USA, Inc. dba Mindray North America based in Mahwah, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 10, 2010. Last inspected February 22, 2024.
Most cited issue areas
- Investigation of device failures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 22, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1251239 |
| April 20, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1062457 |
| March 31, 2016 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 968103 |
| March 10, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 910764 |
| September 23, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 849828 |
| August 2, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 795266 |
| June 10, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 668336 |
No Form 483s, Warning Letters or EIRs on record.
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Name
Mindray DS USA, Inc. dba Mindray North America
FEI Number
2221819
Address
800 Macarthur Blvd, Mahwah, New Jersey 07430, United States
Country
United States
ID: 036bf79f-c69c-44bb-bdd6-65381d7eb1c4