FDA Inspection
Ellis Ophthalmic Technologies, Inc.Ellis Ophthalmic Technologies, Inc. – FDA Inspection, Feb 18, 2015
Record Details
This FDA Inspection record concerns Ellis Ophthalmic Technologies, Inc., with an inspection on February 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 18, 2015
- Product Type
- Devices
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ID · 7c0f3de8-f3b3-486c-9d51-d1835fedc7cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 915089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ellis Ophthalmic Technologies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 25, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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