FDA Inspection 748330 — Bemis Manufacturing Company

Bemis Manufacturing Company — FEI 3000209940

The FDA completed an inspection of Bemis Manufacturing Company on October 4, 2011 in Sheboygan Falls, WI. 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
October 4, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Sheboygan Falls, WI (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation