Company
United StatesSysmex America, Inc., Mundelein, IL – FDA Inspections
Inspection records and compliance data for Sysmex America, Inc. in Mundelein, Illinois. 2 FDA inspections on record, last inspected February 06, 2012.
Company Profile
This profile covers Sysmex 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 October 28, 2009. Last inspected February 6, 2012.
Most cited issue areas
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 769601 |
| October 28, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 626786 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sysmex America, Inc.
FEI Number
1000515253
Address
1 Sysmex Way, Mundelein, Illinois 60060, United States
Country
United States
ID: a58d187e-7c39-434e-9128-4837a184ae5f