Company
United StatesBeckman Coulter, Inc., Chaska, MN – FDA Inspections
Inspection records and compliance data for Beckman Coulter, Inc. in Chaska, Minnesota. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected January 17, 2025.
Company Profile
This profile covers Beckman Coulter, Inc. based in Chaska, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected April 26, 2011. Last inspected January 17, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2025 | Not classified | Medical Devices & Rad Health | 1247509 |
| December 13, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1248406 |
| December 11, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1224836 |
| November 3, 2017 | Not classified | Medical Devices & Rad Health | 1051201 |
| June 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 837631 |
| May 17, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 783029 |
| April 26, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 718260 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Beckman Coulter, Inc.
FEI Number
2122870
Address
1000 Lake Hazeltine Dr, Chaska, Minnesota 55318, United States
Country
United States
ID: 3dff0b83-5add-471e-8c42-4d45ae01cf2b