Company
United StatesGenicon, Inc., Winter Park, FL – FDA Inspections
Inspection records and compliance data for Genicon, Inc. in Winter Park, Florida. 5 FDA inspections on record, 1 Form 483, last inspected January 17, 2020.
Company Profile
This profile covers Genicon, Inc. based in Winter Park, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 7, 2008. Last inspected January 17, 2020.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1115560 |
| October 20, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1029478 |
| April 21, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 923674 |
| March 29, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 775196 |
| November 7, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 548132 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genicon, Inc.
FEI Number
3002590791
Address
6869 Stapoint Ct Ste 112, Winter Park, Florida 32792, United States
Country
United States
ID: d7897305-74e7-4ce7-8b68-558f883e2478