FDA Inspection 1021652 — Arch Medical Solutions - Seabrook, LLC

Arch Medical Solutions - Seabrook, LLC — FEI 1221763

The FDA completed an inspection of Arch Medical Solutions - Seabrook, LLC on August 7, 2017 in Seabrook, NH. 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
August 7, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Seabrook, NH (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures