Company
United StatesGenesiscare, Naples, FL – FDA Inspections
Inspection records and compliance data for Genesiscare in Naples, Florida. 8 FDA inspections on record, 1 Form 483, last inspected April 18, 2023.
Company Profile
This profile covers Genesiscare based in Naples, Florida, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 6
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 12, 2009. Last inspected April 18, 2023.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs4 inspections
- Concurrent documentation3 inspections
- Blood & Blood Components2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2023 | NAI | Biologics · Blood and Blood Products | 1203825 |
| February 25, 2020 | VAI | Biologics · Blood and Blood Products | 1119798 |
| March 12, 2018 | VAI | Biologics · Blood and Blood Products | 1044785 |
| December 17, 2015 | VAI | Biologics · Blood and Blood Products | 954425 |
| May 23, 2014 | VAI | Biologics · Blood and Blood Products | 879728 |
| April 13, 2012 | VAI | Biologics · Blood and Blood Products | 776722 |
| February 24, 2010 | VAI | Biologics · Blood and Blood Products | 649953 |
| February 12, 2009 | NAI | Biologics · Blood and Blood Products | 571146 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genesiscare
FEI Number
3007009870
Address
733 4th Ave N, Naples, Florida 34102, United States
Country
United States
ID: 14d2d975-d3f3-4d79-899f-46e57baef12e