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Bauer & Haselbarth - Chirurg GmbH FDA Record

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

Latest inspection NAI · Mar 19, 2026
Last warning letter 2010

Inspections 5

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Dec 22, 2010

510(k) clearances 0 None on file

Bauer & Haselbarth - Chirurg GmbH has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Bauer & Haselbarth - Chirurg GmbH, the most recent on Dec 22, 2010.

What these totals cover: FDA records filed under the name "Bauer & Haselbarth - Chirurg GmbH" and its spelling variant "Bauer And Haselbarth - Chirurg".

Latest inspection: Mar 19, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Bauer & Haselbarth - Chirurg GmbH's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Bauer & Haselbarth - Chirurg GmbH: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	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	1	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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Bauer & Haselbarth - Chirurg GmbH FDA Warning Letters

1 warning letter on Dec 22, 2010.

Issued	Subject	Issuing office	Close-out letter
Dec 22, 2010 · 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

5 inspections from Sep 16, 2010 to Mar 19, 2026.

Date	Site	Product	Classification	FEI
Mar 19, 2026	Ellerau, Germany	Devices	No Action Indicated (NAI)	3002806450
Dec 15, 2022	Ellerau, Germany	Devices	No Action Indicated (NAI)	3002806450
Jul 11, 2018	Ellerau, Germany	Devices	No Action Indicated (NAI)	3002806450
Sep 15, 2011	Ellerau, Germany	Devices	Voluntary Action Indicated (VAI)	3002806450
Sep 16, 2010	Ellerau, Germany	Devices	Official Action Indicated (OAI)	3002806450

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 Bauer & Haselbarth - Chirurg GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 22, 2010.

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002806450	Ellerau, Germany	5	Mar 19, 2026

Bauer & Haselbarth - Chirurg GmbH and the FDA: common questions

Has Bauer & Haselbarth - Chirurg GmbH received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Bauer & Haselbarth - Chirurg GmbH. The most recent is dated Dec 22, 2010.

Has Bauer & Haselbarth - Chirurg GmbH received an FDA Form 483?

FDA has not published a Form 483 for "Bauer & Haselbarth - Chirurg GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bauer & Haselbarth - Chirurg GmbH?

The most recent FDA inspection on file ended Mar 19, 2026 at Ellerau, Germany and was classified NAI. FDA has 5 inspections of Bauer & Haselbarth - Chirurg GmbH on file, 1 of them classified OAI (official action indicated).

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