FDA Inspection
US IOL, IncUS IOL, Inc – FDA Inspection, Dec 16, 2009
Record Details
This FDA Inspection record concerns US IOL, Inc, with an inspection on December 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- US IOL, Inc
- Inspection Date
- December 16, 2009
- Product Type
- Devices
View Company Profile
ID · 97ab7b15-288f-4b1c-83b9-fa6dd506b9f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634554
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of US IOL, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | Not classified | Cincinnati District Office | |
| August 28, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 9, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for US IOL, Inc
- FDA Inspection 1273427 - 2025-06-05
- FDA Inspection 1102910 - 2019-08-28
- FDA Inspection 980185 - 2016-06-08
- FDA Inspection 802559 - 2012-10-09
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