FDA Inspection
Beckman Coulter, Inc.Beckman Coulter, Inc. – FDA Inspection, Dec 11, 2023
Record Details
This FDA Inspection record concerns Beckman Coulter, Inc., with an inspection on December 11, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 633ab933-b437-41ab-bddc-974a61dab3c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1224836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Beckman Coulter, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | Not classified | Minneapolis District Office | |
| December 13, 2024 | Not classified | Minneapolis District Office | Compliance: Medical Devices |
| November 3, 2017 | Not classified | Minneapolis District Office | |
| June 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Beckman Coulter, Inc.
- FDA Inspection 1247509 - 2025-01-17
- FDA Inspection 1248406 - 2024-12-13
- FDA Inspection 1051201 - 2017-11-03
- FDA Inspection 837631 - 2013-06-19
- FDA Inspection 783029 - 2012-05-17
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