FDA Inspection 1181983 — WORLD SOURCE SIMPLE LLC

WORLD SOURCE SIMPLE LLC — FEI 3014527907

The FDA completed an inspection of WORLD SOURCE SIMPLE LLC on October 24, 2022 in Lima, 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
October 24, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Lima, OH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
63021 CFR 803.17Lack of Written MDR Procedures