Drug factory · FDA FEI 3002807481

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6, Bad Bocklet, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 14, 2022.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
DeferoxamineTests it Mitem Pharma 87081-467
Gadolinium Cation (3+)Tests it Bracco Diagnostics Inc. 0270-5164, 0270-5264
GadoteridolTests it Bracco Diagnostics Inc. 0270-1111
GemcitabineTests it Janssen Biotech, Inc. 57894-225
Glycerin and Hydroxyethyl Cellulose (5500 Mpa.s At 2%) and WaterTests it Giskit Pharma B.v. 73254-310
IopamidolTests it Bracco Diagnostics Inc. 0270-1314, 0270-1315, 0270-1316 +3
NeratinibTests it Puma Biotechnology, Inc. 70437-240
TriheptanoinTests it Ultragenyx Pharmaceutical Inc. 69794-050

FDA inspection history

EndedResultProgramProblems noted
Dec 14, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 4, 2016No problems foundDrug Quality Assurance—
May 12, 2015No problems foundDrug Quality Assurance—
Jan 28, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 21, 2011Serious problems, FDA actionDrug Quality Assurance—
May 6, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis.