FDA Inspection 1017929 — Denali R & D Corporation

Denali R & D Corporation — FEI 3006367836

The FDA completed an inspection of Denali R & D Corporation on July 12, 2017 in Hanover, 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
July 12, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Hanover, MA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures