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Rommelag CDMO Switzerland AG

FDA Regulatory Profile

Rommelag CDMO Switzerland AG has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection
Feb 11, 2022 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

3 inspections from Sep 20, 2013 to Feb 11, 2022.

DateSiteProductClassificationFEI
Feb 11, 2022Zell Lu, SwitzerlandDrugsVoluntary Action Indicated (VAI)3004079469
Jul 3, 2015Zell Lu, SwitzerlandDrugsNo Action Indicated (NAI)3004079469
Sep 20, 2013Zell Lu, SwitzerlandDrugsVoluntary Action Indicated (VAI)3004079469
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.

FacilityLocationInspectionsLatest
FEI 3004079469Zell Lu, Switzerland3Feb 11, 2022

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.