Company
United StatesGuardian Medical USA Inc., Swanton, OH – FDA Inspections
Inspection records and compliance data for Guardian Medical USA Inc. in Swanton, Ohio. 2 FDA inspections on record, 1 Form 483, last inspected June 02, 2026.
Company Profile
This profile covers Guardian Medical USA Inc. based in Swanton, Ohio, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 24, 2022. Last inspected June 2, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Criteria for the evaluation and selection of suppliers not established1 inspection
- Design and development transfer procedures not documented1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 2, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1320072 |
| June 24, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1174256 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Guardian Medical USA Inc.
FEI Number
3016261131
Address
11360 S Airfield Rd, Swanton, Ohio 43558, United States
Country
United States
ID: cc973eb8-b4e0-4b77-837e-0e72c3b13a23