Company
United StatesMedstrat, Inc., Downers Grove, IL – FDA Inspections
Inspection records and compliance data for Medstrat, Inc. in Downers Grove, Illinois. 4 FDA inspections on record, 1 Form 483, last inspected February 05, 2026.
Company Profile
This profile covers Medstrat, Inc. based in Downers Grove, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 27, 2016. Last inspected February 5, 2026.
Most cited issue areas
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2026 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1304426 |
| March 10, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1164141 |
| November 9, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1071863 |
| September 27, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 985581 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medstrat, Inc.
FEI Number
3003574171
Address
1901 Butterfield Rd Ste 600, Downers Grove, Illinois 60515, United States
Country
United States
ID: 87ce10ef-e371-4c35-aa1e-2eca84aca16d