FDA Inspection 1157918 — Schoelly USA Inc

Schoelly USA Inc — FEI 3016667340

The FDA completed an inspection of Schoelly USA Inc on December 1, 2021 in Northborough, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 1, 2021
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Northborough, MA (United States)

Citations

IDCFRDescription
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures