Company
United StatesGenia Medical, Inc., Orlando, FL – FDA Inspections
Inspection records and compliance data for Genia Medical, Inc. in Orlando, Florida. 2 FDA inspections on record, 1 Form 483, last inspected February 15, 2024.
Company Profile
This profile covers Genia Medical, Inc. based in Orlando, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 17, 2017. Last inspected February 15, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1233376 |
| April 17, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1012875 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Genia Medical, Inc.
FEI Number
3004157007
Address
121 S Orange Ave Ste 1000, Orlando, Florida 32801, United States
Country
United States
ID: 8c6d19e9-ea1d-4a34-a35c-f4adbb230243