FDA Inspection 936923 — Diasol, Inc

Diasol, Inc — FEI 3007137482

The FDA completed an inspection of Diasol, Inc on August 3, 2015 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 3, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Phoenix, AZ (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
326921 CFR 820.80(b)Incoming acceptance records, documentation
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation