FDA Inspection
Maquet Cardiovascular, LLCMaquet Cardiovascular, LLC – FDA Inspection, Jul 11, 2024
Record Details
This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on July 11, 2024, covering devices.
- Company
- Maquet Cardiovascular, LLC
- Inspection Date
- July 11, 2024
- Product Type
- Devices
- People
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ID · d21d9fab-8b78-41ee-899e-fe4909a8c493
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1230807
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Showing 10 of 11 citations.
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Other FDA inspections of Maquet Cardiovascular, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 29, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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