Company
United StatesIBT Scientific Llc, Elkhart, IN – FDA Inspections
Inspection records and compliance data for IBT Scientific Llc in Elkhart, Indiana. 6 FDA inspections on record, 1 Form 483, last inspected December 19, 2025.
Company Profile
This profile covers IBT Scientific Llc based in Elkhart, Indiana, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected August 7, 2009. Last inspected December 19, 2025.
Most cited issue areas
- Calibration procedures - content1 inspection
- Lack of or inadequate process validation1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1298010 |
| December 19, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1113756 |
| June 23, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016806 |
| March 18, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 870074 |
| March 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 774751 |
| August 7, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 607733 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
IBT Scientific Llc
FEI Number
1000139989
Address
2931 Moose Trl, Elkhart, Indiana 46514, United States
Country
United States
ID: 23006df3-243c-437d-9d91-8ffe07381499