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LISI MEDICAL Remmele, Inc. FDA Record

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

LISI MEDICAL Remmele, Inc. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "LISI MEDICAL Remmele, Inc." is on file.

What these totals cover: FDA records filed under the name "LISI MEDICAL Remmele, Inc." and its spelling variant "Lisi Medical Remmele".

Latest inspection: May 1, 2025 · VAI

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	8	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

LISI MEDICAL Remmele, 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	1	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	2	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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Recent FDA inspections

8 inspections from Feb 4, 2009 to May 1, 2025.

Date	Site	Product	Classification	FEI
May 1, 2025	Coon Rapids, MN	Devices	Voluntary Action Indicated (VAI)	3000203391
Apr 27, 2023	Big Lake, MN	Devices	Voluntary Action Indicated (VAI)	3009941480
Jul 12, 2022	Coon Rapids, MN	Devices	Voluntary Action Indicated (VAI)	3000203391
Jan 26, 2018	Coon Rapids, MN	Devices	No Action Indicated (NAI)	3000203391
Jan 18, 2018	Big Lake, MN	Devices	No Action Indicated (NAI)	3009941480
Jan 14, 2015	Big Lake, MN	Devices	No Action Indicated (NAI)	3009941480
Jan 14, 2015	Coon Rapids, MN	Devices	No Action Indicated (NAI)	3000203391
Feb 4, 2009	Coon Rapids, MN	Devices	No Action Indicated (NAI)	3000203391

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3000203391	Coon Rapids, MN	5	May 1, 2025
FEI 3009941480	Big Lake, MN	3	Apr 27, 2023

LISI MEDICAL Remmele, Inc. and the FDA: common questions

Has LISI MEDICAL Remmele, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "LISI MEDICAL Remmele, Inc." 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 LISI MEDICAL Remmele, Inc. received an FDA Form 483?

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

When did the FDA last inspect LISI MEDICAL Remmele, Inc.?

The most recent FDA inspection on file ended May 1, 2025 at Coon Rapids, MN and was classified VAI. FDA has 8 inspections of LISI MEDICAL Remmele, Inc. on file.

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