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Wannemacher Enterprises Inc FDA Record

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

Wannemacher Enterprises Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Wannemacher Enterprises Inc, the most recent on Jun 1, 2012.

What these totals cover: FDA records filed under the name "Wannemacher Enterprises Inc" and its spelling variant "Wannemacher Enterprises".

Latest inspection: Mar 12, 2025 · NAI

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	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Wannemacher Enterprises Inc'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.

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Wannemacher Enterprises Inc FDA Warning Letters

1 warning letter on Jun 1, 2012.

Issued	Subject	Issuing office	Close-out letter
Jun 1, 2012 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

7 inspections from May 27, 2010 to Mar 12, 2025.

Date	Site	Product	Classification	FEI
Mar 12, 2025	Lima, OH	Food/Cosmetics	No Action Indicated (NAI)	1000122571
Mar 27, 2019	Lima, OH	Food/Cosmetics	Voluntary Action Indicated (VAI)	1000122571
Mar 31, 2016	Lima, OH	Food/Cosmetics	No Action Indicated (NAI)	1000122571
Sep 3, 2014	Lima, OH	Food/Cosmetics	No Action Indicated (NAI)	3010243845
Dec 12, 2012	Lima, OH	Food/Cosmetics	No Action Indicated (NAI)	1000122571
Apr 17, 2012	Lima, OH	Food/Cosmetics	Official Action Indicated (OAI)	1000122571
May 27, 2010	Lima, OH	Food/Cosmetics	Voluntary Action Indicated (VAI)	1000122571

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Wannemacher Enterprises Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 1, 2012.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000122571	Lima, OH	6	Mar 12, 2025
FEI 3010243845	Lima, OH	1	Sep 3, 2014

Wannemacher Enterprises Inc and the FDA: common questions

Has Wannemacher Enterprises Inc received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Wannemacher Enterprises Inc. The most recent is dated Jun 1, 2012.

Has Wannemacher Enterprises Inc received an FDA Form 483?

FDA has not published a Form 483 for "Wannemacher Enterprises Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Wannemacher Enterprises Inc?

The most recent FDA inspection on file ended Mar 12, 2025 at Lima, OH and was classified NAI. FDA has 7 inspections of Wannemacher Enterprises Inc on file, 1 of them classified OAI (official action indicated).

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