FDA Inspection 905565 — Preventive Technologies Inc

Preventive Technologies Inc — FEI 1000511545

The FDA completed an inspection of Preventive Technologies Inc on Nov 21, 2014 in Indian Trail, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 21, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Indian Trail, NC (United States)

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
320721 CFR 820.50(b)Supplier notification of changes
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures