FDA Inspection 1024060 — NCS Pearson

NCS Pearson — FEI 3006224965

The FDA completed an inspection of NCS Pearson on August 17, 2017 in Boston, MA. 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
August 17, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Boston, MA (United States)

Citations

IDCFRDescription
341521 CFR 820.22Quality Audit/Reaudit - conducted
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency