FDA Inspection
Maquet Cardiovascular, LLCMaquet Cardiovascular, LLC – FDA Inspection, May 14, 2010
Record Details
This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on May 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maquet Cardiovascular, LLC
- Inspection Date
- May 14, 2010
- Product Type
- Devices
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ID · 715b59b6-87e0-4c6d-a49f-e3f6d042f807
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 659860
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Maquet Cardiovascular, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2024 | OAI | Postmarket Assurance: Devices | |
| 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 |
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