Company
United StatesDeGen Medical Inc., Florence, SC – FDA Inspections
Inspection records and compliance data for DeGen Medical Inc. in Florence, South Carolina. 2 FDA inspections on record, 2 Form 483s, last inspected September 12, 2024.
Company Profile
This profile covers DeGen Medical Inc. based in Florence, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 29, 2019. Last inspected September 12, 2024.
Most cited issue areas
- Design validation - simulated testing1 inspection
- Design validation - user needs and intended uses1 inspection
- Investigation of device failures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1249105 |
| August 29, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1101189 |
FDA documents
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Company Information
Name
DeGen Medical Inc.
FEI Number
3010663372
Address
1321c N Cashua Dr, Florence, South Carolina 29501, United States
Country
United States
ID: 6093eda0-b69b-437f-bc3e-978d0f0eb18c