Company
United StatesBeckman Coulter, Inc., Miami, FL – FDA Inspections
Inspection records and compliance data for Beckman Coulter, Inc. in Miami, Florida. 5 FDA inspections on record (1 OAI), 2 Form 483s, last inspected October 28, 2021.
Company Profile
This profile covers Beckman Coulter, Inc. based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 2, 2011. Last inspected October 28, 2021.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Lack of Written MDR Procedures2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1155995 |
| December 8, 2017 | Not classified | Medical Devices & Rad Health | 1081378 |
| October 16, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1028860 |
| September 11, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 848046 |
| June 2, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 729388 |
FDA documents
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Company Information
Name
Beckman Coulter, Inc.
FEI Number
3000203293
Address
11800 Sw 147th Ave, Miami, Florida 33196, United States
Country
United States
ID: 9b3a1a9b-0669-427d-ae51-613657b8cd22