FDA Inspection 944355 — JW North America, Inc.

JW North America, Inc. — FEI 1450790

The FDA completed an inspection of JW North America, Inc. on September 21, 2015 in Rockland, 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
September 21, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Rockland, MA (United States)

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures