Company
United StatesSysmex Reagents America, Inc., Mundelein, IL – FDA Inspections
Inspection records and compliance data for Sysmex Reagents America, Inc. in Mundelein, Illinois. 2 FDA inspections on record, last inspected June 07, 2016.
Company Profile
This profile covers Sysmex Reagents America, Inc. based in Mundelein, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 6, 2012. Last inspected June 7, 2016.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 984894 |
| February 6, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 773199 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sysmex Reagents America, Inc.
FEI Number
3006949423
Address
2 Sysmex Way, Mundelein, Illinois 60060, United States
Country
United States
ID: 42ccad2d-3cba-49aa-995f-28e3c6b0eab7