FDA Inspection 915990 — Maxx Ortopedics Inc

Maxx Ortopedics Inc — FEI 3007311878

The FDA completed an inspection of Maxx Ortopedics Inc on February 27, 2015 in West Norriton, PA. 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
February 27, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
West Norriton, PA (United States)

Citations

IDCFRDescription
320721 CFR 820.50(b)Supplier notification of changes
368321 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements