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Bemis Manufacturing Company FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Bemis Manufacturing Company has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bemis Manufacturing Company" is on file.

What these totals cover: FDA records filed under the name "Bemis Manufacturing Company" and its spelling variant "Bemis Manufacturing".

Latest inspection: Apr 30, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Bemis Manufacturing Company's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

3 inspections from Oct 4, 2011 to Apr 30, 2025.

Date	Site	Product	Classification	FEI
Apr 30, 2025	Sheboygan Falls, WI	Devices	No Action Indicated (NAI)	3000209940
Aug 14, 2019	Sheboygan Falls, WI	Devices	No Action Indicated (NAI)	3000209940
Oct 4, 2011	Sheboygan Falls, WI	Devices	Voluntary Action Indicated (VAI)	3000209940

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3000209940	Sheboygan Falls, WI	3	Apr 30, 2025

Bemis Manufacturing Company and the FDA: common questions

Has Bemis Manufacturing Company received an FDA warning letter?

No FDA warning letter addressed to the name "Bemis Manufacturing Company" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Bemis Manufacturing Company received an FDA Form 483?

FDA has not published a Form 483 for "Bemis Manufacturing Company" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bemis Manufacturing Company?

The most recent FDA inspection on file ended Apr 30, 2025 at Sheboygan Falls, WI and was classified NAI. FDA has 3 inspections of Bemis Manufacturing Company on file.

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