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Biologische Heilmittel Heel Gmbh FDA Record

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

Latest inspection VAI · Apr 26, 2023
No warning letters matched by name

Inspections 5

1 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Biologische Heilmittel Heel Gmbh has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Biologische Heilmittel Heel Gmbh" is on file.

What these totals cover: FDA records filed under the name "Biologische Heilmittel Heel Gmbh" and its spelling variant "Biologische Heilmittel Heel".

Latest inspection: Apr 26, 2023 · 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	5	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

Biologische Heilmittel Heel Gmbh's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Biologische Heilmittel Heel Gmbh: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	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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Recent FDA inspections

5 inspections from Jul 22, 2010 to Apr 26, 2023.

Date	Site	Product	Classification	FEI
Apr 26, 2023	Baden-Baden, Germany	Drugs	Voluntary Action Indicated (VAI)	3002806504
Feb 1, 2019	Baden-Baden, Germany	Drugs	Voluntary Action Indicated (VAI)	3002806504
May 3, 2016	Baden-Baden, Germany	Drugs	Voluntary Action Indicated (VAI)	3002806504
Oct 31, 2012	Baden-Baden, Germany	Drugs	Official Action Indicated (OAI)	3002806504
Jul 22, 2010	Baden-Baden, Germany	Drugs	No Action Indicated (NAI)	3002806504

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 3002806504	Baden-Baden, Germany	5	Apr 26, 2023

Biologische Heilmittel Heel Gmbh and the FDA: common questions

Has Biologische Heilmittel Heel Gmbh received an FDA warning letter?

No FDA warning letter addressed to the name "Biologische Heilmittel Heel Gmbh" 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 Biologische Heilmittel Heel Gmbh received an FDA Form 483?

FDA has not published a Form 483 for "Biologische Heilmittel Heel Gmbh" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Biologische Heilmittel Heel Gmbh?

The most recent FDA inspection on file ended Apr 26, 2023 at Baden-Baden, Germany and was classified VAI. FDA has 5 inspections of Biologische Heilmittel Heel Gmbh on file, 1 of them classified OAI (official action indicated).

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