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Rommelag CDMO GmbH

FDA Regulatory Profile

Rommelag CDMO GmbH has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Rommelag CDMO GmbH" and its spelling variant "Rommelag Cdmo".

Latest inspection: Mar 20, 2025 · VAI

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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	11	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	1	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.

Recent FDA inspections

11 inspections from Nov 19, 2009 to Mar 20, 2025.

Date	Site	Product	Classification	FEI
Mar 20, 2025	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 9, 2023	Sulzbach-Laufen, Germany	Devices	No Action Indicated (NAI)	3002808845
Apr 5, 2022	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 18, 2020	Sulzbach-Laufen, Germany	Veterinary	No Action Indicated (NAI)	3002808845
Sep 17, 2019	Sulzbach-Laufen, Germany	Drugs	No Action Indicated (NAI)	3002808845
Oct 22, 2015	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 14, 2014	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 12, 2014	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 24, 2012	Sulzbach-Laufen, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808845
Feb 17, 2012	Sulzbach-Laufen, Germany	Drugs	No Action Indicated (NAI)	3002808845
Nov 19, 2009	Sulzbach-Laufen, Germany	Devices	No Action Indicated (NAI)	3002808845

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 3002808845	Sulzbach-Laufen, Germany	11	Mar 20, 2025

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