Labor LS SE & Co. KG
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Germany
- Registered address
- Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708, Germany (DEU)
- Operations here
- analysis
- FDA identifiers
- FEI 3002807481 · DUNS 314929072
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2016-11-04
- NAIDrug Quality Assurance2015-05-12
- VAIDrug Quality Assurance2013-01-28
- OAIDrug Quality Assurance2011-07-21
- VAIDrug Quality Assurance2009-05-06
Drugs this plant is listed as making
7 distinct drugs across 13 products name this site in their FDA label.
- Air Polymer-Type A Intrauterine FoamGiskit Pharma B.v.
- deferoxamine mesylateMitem Pharma
- gadobenate dimeglumineBracco Diagnostics Inc
- gadoteridolBracco Diagnostics Inc
- gemcitabine intravesicalJanssen Biotech, Inc
- IopamidolBracco Diagnostics Inc
- TriheptanoinUltragenyx Pharmaceutical Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.