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Rentschler Biopharma SE FDA Record

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

Latest inspection VAI · May 5, 2023
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Rentschler Biopharma SE has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rentschler Biopharma SE" is on file. FDA has published 2 Form 483s for Rentschler Biopharma SE.

What these totals cover: FDA records filed under the name "Rentschler Biopharma SE".

Latest inspection: May 5, 2023 · VAI

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	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Rentschler Biopharma SE: 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	1	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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Rentschler Biopharma SE Form 483s

2 Form 483s published by FDA.

Date	Document	FEI
Mar 7, 2023 · Document on fda.gov	483	1000291122
Feb 15, 2022 · Document on fda.gov	483	1000291122

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

7 inspections from Jul 19, 2011 to May 5, 2023.

Date	Site	Product	Classification	FEI
May 5, 2023	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122
Feb 26, 2021	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122
Aug 9, 2019	Laupheim, Germany	Drugs	No Action Indicated (NAI)	1000291122
Dec 6, 2016	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122
Jun 16, 2015	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122
Sep 20, 2013	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122
Jul 19, 2011	Laupheim, Germany	Drugs	Voluntary Action Indicated (VAI)	1000291122

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 1000291122	Laupheim, Germany	7	May 5, 2023

Rentschler Biopharma SE and the FDA: common questions

Has Rentschler Biopharma SE received an FDA warning letter?

No FDA warning letter addressed to the name "Rentschler Biopharma SE" 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 Rentschler Biopharma SE received an FDA Form 483?

FDA has published 2 Form 483s for Rentschler Biopharma SE in its reading room, the most recent dated Mar 7, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Rentschler Biopharma SE?

The most recent FDA inspection on file ended May 5, 2023 at Laupheim, Germany and was classified VAI. FDA has 7 inspections of Rentschler Biopharma SE on file.

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