Company
United StatesTrek Diagnostics Systems Inc. (dba Thermo Fisher Scientific), Sun Prairie, WI – FDA Inspections
Inspection records and compliance data for Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific) in Sun Prairie, Wisconsin. 2 FDA inspections on record, last inspected February 07, 2012.
Company Profile
This profile covers Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific) based in Sun Prairie, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 16, 2009. Last inspected February 7, 2012.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 7, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 770957 |
| March 16, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 570301 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific)
FEI Number
2183729
Address
210 Business Park Dr, Sun Prairie, Wisconsin 53590, United States
Country
United States
ID: 2191199f-2523-499d-b8f2-2a3bb1621abe