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Rommelag CDMO GmbH — FDA Facility Profile

FEI 3002808845

Rommelag CDMO GmbH is an FDA-registered facility (FEI 3002808845) located in Sulzbach-Laufen Baden-Wurttemberg, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 11 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 20, 2025: Voluntary Action Indicated (VAI)
Inspections on record
11 (6 VAI, 5 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
7

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 20, 2025Voluntary Action Indicated (VAI)No citations listed
Feb 9, 2023No Action Indicated (NAI)No citations listed
Apr 5, 2022Voluntary Action Indicated (VAI)No citations listed
Feb 18, 2020No Action Indicated (NAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Validation lacking for sterile drug products (21 CFR 211.113(b))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Sep 17, 2019No Action Indicated (NAI)No citations listed
Oct 22, 2015Voluntary Action Indicated (VAI)No citations listed
Feb 14, 2014Voluntary Action Indicated (VAI)No citations listed
Feb 12, 2014Voluntary Action Indicated (VAI)No citations listed
Feb 24, 2012Voluntary Action Indicated (VAI)No citations listed
Feb 17, 2012No Action Indicated (NAI)No citations listed

Facility details

Company
Rommelag CDMO GmbH
Location
Sulzbach-Laufen Baden-Wurttemberg (DE)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
both

Import refusals

FDA data resources

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