FDA Inspection 808126 — M.E.E.I. Boston Keratoprosthesis

M.E.E.I. Boston Keratoprosthesis — FEI 1000120597

The FDA completed an inspection of M.E.E.I. Boston Keratoprosthesis on November 20, 2012 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Boston, MA (United States)

Citations

IDCFRDescription
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate