FDA Inspection
Hoya Surgical Optics, Inc.Hoya Surgical Optics, Inc. – FDA Inspection, Nov 19, 2012
Record Details
This FDA Inspection record concerns Hoya Surgical Optics, Inc., with an inspection on November 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hoya Surgical Optics, Inc.
- Inspection Date
- November 19, 2012
- Product Type
- Devices
View Company Profile
ID · 628c5ab7-5f6e-4055-b46d-462f22d58788
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809074
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hoya Surgical Optics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 15, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hoya Surgical Optics, Inc.
- FDA Inspection 932339 - 2015-06-10
- FDA Inspection 620299 - 2009-10-15
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