FDA Inspection 1277414 — STERIS Laboratories, Inc.

STERIS Laboratories, Inc. — FEI 2183828

The FDA completed an inspection of STERIS Laboratories, Inc. on August 1, 2025 in Brooklyn Park, MN. 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 1, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Brooklyn Park, MN (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures