FDA Inspection 1281790 — Henke Sass Wolf Of America,Inc

Henke Sass Wolf Of America,Inc — FEI 1000120548

The FDA completed an inspection of Henke Sass Wolf Of America,Inc on September 16, 2025 in Dudley, 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 16, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Dudley, MA (United States)

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities