BEMIS MANUFACTURING CO. FDA Inspection Record

FEI 3000209940 · Inspections, Form 483s, warning letters and import refusals

BEMIS MANUFACTURING CO. is an FDA-registered facility (FEI 3000209940) located in Sheboygan Falls, WI, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 30, 2025: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 30, 2025No Action Indicated (NAI)No citations listed
Aug 14, 2019No Action Indicated (NAI)Design input - Lack of or inadequate procedures (21 CFR 820.30(c))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Oct 4, 2011Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate process validation (21 CFR 820.75(a))

Facility details

Company
Bemis Manufacturing Company
Location
Sheboygan Falls, WI (US)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.