Company
United StatesEyeKon Medical, Inc., Clearwater, FL – FDA Inspections
Inspection records and compliance data for EyeKon Medical, Inc. in Clearwater, Florida. 5 FDA inspections on record (1 OAI), 2 Form 483s, last inspected June 10, 2025.
Company Profile
This profile covers EyeKon Medical, Inc. based in Clearwater, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected October 3, 2008. Last inspected June 10, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 10, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1251720 |
| February 16, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1042012 |
| November 28, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 809132 |
| June 12, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 588902 |
| October 3, 2008 | OAI | Medical Devices & Rad Health · Compliance: Devices | 540097 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
EyeKon Medical, Inc.
FEI Number
1038833
Address
2451 Enterprise Rd, Clearwater, Florida 33763, United States
Country
United States
ID: 6fbf6bc2-bcfe-45db-b7ff-e329fafaca6c