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Micronisierungs-Kontor Oberrot GmbH FDA Record

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

Latest inspection VAI · Jan 11, 2023
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Micronisierungs-Kontor Oberrot GmbH has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Micronisierungs-Kontor Oberrot GmbH" is on file.

What these totals cover: FDA records filed under the name "Micronisierungs-Kontor Oberrot GmbH" and its spelling variant "Micronisierungs-Kontor Oberrot".

Latest inspection: Jan 11, 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	3	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

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

Micronisierungs-Kontor Oberrot 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	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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Recent FDA inspections

3 inspections from Mar 17, 2016 to Jan 11, 2023.

Date	Site	Product	Classification	FEI
Jan 11, 2023	Oberrot, Germany	Drugs	Voluntary Action Indicated (VAI)	3005909896
Feb 5, 2020	Oberrot, Germany	Drugs	Voluntary Action Indicated (VAI)	3005909896
Mar 17, 2016	Oberrot, Germany	Drugs	Voluntary Action Indicated (VAI)	3005909896

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 3005909896	Oberrot, Germany	3	Jan 11, 2023

Micronisierungs-Kontor Oberrot GmbH and the FDA: common questions

Has Micronisierungs-Kontor Oberrot GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Micronisierungs-Kontor Oberrot 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 Micronisierungs-Kontor Oberrot GmbH received an FDA Form 483?

FDA has not published a Form 483 for "Micronisierungs-Kontor Oberrot GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Micronisierungs-Kontor Oberrot GmbH?

The most recent FDA inspection on file ended Jan 11, 2023 at Oberrot, Germany and was classified VAI. FDA has 3 inspections of Micronisierungs-Kontor Oberrot GmbH on file.

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