Company
United StatesMedicatech Usa, Irvine, CA – FDA Inspections
Inspection records and compliance data for Medicatech Usa in Irvine, California. 2 FDA inspections on record, 1 Form 483, last inspected October 22, 2024.
Company Profile
This profile covers Medicatech Usa based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 19, 2010. Last inspected October 22, 2024.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1252312 |
| December 19, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 702863 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medicatech Usa
FEI Number
3004989804
Address
50 Maxwell, Irvine, California 92618, United States
Country
United States
ID: 0b4c7367-33e5-40ff-92c9-2c679defffb0