Company
United StatesUS IOL, Inc, Lexington, KY – FDA Inspections
Inspection records and compliance data for US IOL, Inc in Lexington, Kentucky. 5 FDA inspections on record, last inspected June 05, 2025.
Company Profile
This profile covers US IOL, Inc based in Lexington, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 16, 2009. Last inspected June 5, 2025.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2025 | Not classified | Medical Devices & Rad Health | 1273427 |
| August 28, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1102910 |
| June 8, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 980185 |
| October 9, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 802559 |
| December 16, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 634554 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
US IOL, Inc
FEI Number
1037089
Address
2500 Sandersville Rd, Lexington, Kentucky 40511, United States
Country
United States
ID: d63f9e7f-6eb2-435d-99ef-313572e6b1dd