FDA Inspection
M.E.E.I. Boston KeratoprosthesisM.E.E.I. Boston Keratoprosthesis – FDA Inspection, Nov 20, 2012
Record Details
This FDA Inspection record concerns M.E.E.I. Boston Keratoprosthesis, with an inspection on November 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2012
- Product Type
- Devices
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ID · 23868af9-0082-4337-a044-ba8af4396a5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808126
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of M.E.E.I. Boston Keratoprosthesis
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 23, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for M.E.E.I. Boston Keratoprosthesis
- FDA Inspection 1024977 - 2017-07-25
- FDA Inspection 613689 - 2009-09-23
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