Company
United StatesMaquet Cardiovascular, LLC, Wayne, NJ – FDA Inspections
Inspection records and compliance data for Maquet Cardiovascular, LLC in Wayne, New Jersey. 8 FDA inspections on record (6 OAI), last inspected July 11, 2024.
Company Profile
This profile covers Maquet Cardiovascular, LLC based in Wayne, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 6
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 17, 2009. Last inspected July 11, 2024.
Most cited issue areas
- Individual Report of Malfunction6 inspections
- Lack of or inadequate procedures6 inspections
- Report of Death or Serious Injury6 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2024 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1230807 |
| February 26, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1136869 |
| September 29, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 994785 |
| October 16, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 851685 |
| June 14, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 778533 |
| April 1, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 715434 |
| May 14, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 659860 |
| April 17, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 578055 |
FDA documents
Form 483s (1)
- Form 483s · February 26, 2021
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Company Information
Name
Maquet Cardiovascular, LLC
FEI Number
2242352
Address
45 Barbour Pond Dr, Wayne, New Jersey 07470, United States
Country
United States
ID: d9a17f88-a7b5-471c-8afc-4b6d4e8750ac