Company
United StatesGalt Medical Corporation, Garland, TX – FDA Inspections
Inspection records and compliance data for Galt Medical Corporation in Garland, Texas. 4 FDA inspections on record, last inspected January 08, 2026.
Company Profile
This profile covers Galt Medical Corporation based in Garland, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 19, 2011. Last inspected January 8, 2026.
Most cited issue areas
- Design validation- Lack of or inadequate procedures2 inspections
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 8, 2026 | Not classified | Medical Devices & Rad Health | 1301774 |
| September 15, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 996096 |
| December 20, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 859195 |
| January 19, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 709001 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Galt Medical Corporation
FEI Number
3000718472
Address
2220 Merritt Dr, Garland, Texas 75041, United States
Country
United States
ID: 91f8c8a9-6c30-4584-a12d-8dd9d0e31d8a