Company
United StatesGenoray America Inc., Orange, CA – FDA Inspections
Inspection records and compliance data for Genoray America Inc. in Orange, California. 1 FDA inspection on record, 1 Form 483, last inspected August 17, 2018.
Company Profile
This profile covers Genoray America Inc. based in Orange, California, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected August 17, 2018.
Most cited issue areas
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 17, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1062606 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genoray America Inc.
FEI Number
3007538876
Address
147 E Bristol Ln, Orange, California 92865, United States
Country
United States
ID: 2883e76a-b9a9-4b90-9117-6a343785a936