FDA Inspection 853836 — Diamond Diagnostics, Inc.

Diamond Diagnostics, Inc. — FEI 3003030793

The FDA completed an inspection of Diamond Diagnostics, Inc. on October 23, 2013 in Holliston, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 23, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Holliston, MA (United States)

Citations

IDCFRDescription
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events