FDA Inspection 979976 — Troy Innovative Instruments Inc

Troy Innovative Instruments Inc — FEI 3000718985

The FDA completed an inspection of Troy Innovative Instruments Inc on August 3, 2016 in Middlefield, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 3, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Middlefield, OH (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures