Company
United StatesMAC Medical Inc., Millstadt, IL – FDA Inspections
Inspection records and compliance data for MAC Medical Inc. in Millstadt, Illinois. 4 FDA inspections on record, last inspected September 16, 2026.
Company Profile
This profile covers MAC Medical Inc. based in Millstadt, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 8, 2010. Last inspected September 16, 2026.
Most cited issue areas
- External party controls do not include written quality agreements1 inspection
- Monitoring and measurement requirements not determined1 inspection
- Monitoring and measurement requirements of product characteristics are not met1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2026 | VAI | · Compliance: Devices | 1335940 |
| July 26, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1023514 |
| May 29, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 783668 |
| October 8, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 684786 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MAC Medical Inc.
FEI Number
3006342679
Address
820 S Mulberry St, Millstadt, Illinois 62260, United States
Country
United States
ID: dfa59d4b-4c24-4ba0-86dc-7e2b991fbfde