Company
United StatesGauthier Biomedical, Inc., Grafton, WI – FDA Inspections
Inspection records and compliance data for Gauthier Biomedical, Inc. in Grafton, Wisconsin. 3 FDA inspections on record, 1 Form 483, last inspected January 08, 2025.
Company Profile
This profile covers Gauthier Biomedical, Inc. based in Grafton, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 15, 2016. Last inspected January 8, 2025.
Most cited issue areas
- Adverse events--all info not in file2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 8, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1258347 |
| December 21, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1159937 |
| December 15, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 998349 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Gauthier Biomedical, Inc.
FEI Number
3010938185
Address
2221 Washington St, Grafton, Wisconsin 53024, United States
Country
United States
ID: bf287207-fc1f-4b2e-963d-3f0c33b1bcec