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IDT Biologika GmbH FDA Record

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

Latest inspection VAI · Sep 8, 2023
No warning letters matched by name

Inspections 6

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

IDT Biologika GmbH has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "IDT Biologika GmbH" is on file. FDA has published 1 Form 483 for IDT Biologika GmbH.

What these totals cover: FDA records filed under the name "IDT Biologika GmbH" and its spelling variant "Idt Biologika".

Latest inspection: Sep 8, 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	6	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

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

IDT Biologika 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	2	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	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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IDT Biologika GmbH Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Sep 8, 2023 · Document on fda.gov	483	3005001757

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

6 inspections from Oct 18, 2012 to Sep 8, 2023.

Date	Site	Product	Classification	FEI
Sep 8, 2023	Dessau-Rosslau, Germany	Biologics	Voluntary Action Indicated (VAI)	3005001757
Aug 25, 2023	Dessau-Rosslau, Germany	Drugs	Voluntary Action Indicated (VAI)	3005001757
Sep 10, 2020	Dessau-Rosslau, Germany	Drugs	Voluntary Action Indicated (VAI)	3005001757
Nov 22, 2016	Dessau-Rosslau, Germany	Drugs	Voluntary Action Indicated (VAI)	3005001757
Dec 9, 2014	Dessau-Rosslau, Germany	Drugs	Voluntary Action Indicated (VAI)	3005001757
Oct 18, 2012	Dessau-Rosslau, Germany	Drugs	No Action Indicated (NAI)	3005001757

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 3005001757	Dessau-Rosslau, Germany	6	Sep 8, 2023

IDT Biologika GmbH and the FDA: common questions

Has IDT Biologika GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "IDT Biologika 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 IDT Biologika GmbH received an FDA Form 483?

FDA has published 1 Form 483 for IDT Biologika GmbH in its reading room, the most recent dated Sep 8, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect IDT Biologika GmbH?

The most recent FDA inspection on file ended Sep 8, 2023 at Dessau-Rosslau, Germany and was classified VAI. FDA has 6 inspections of IDT Biologika GmbH on file.

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