BIPSO GmbH
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
- Robert-Gerwig-Str. 4, Singen (Hohentwiel), 78224, Germany (DEU)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3009099058 · DUNS 342104149
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-05-04
- VAIDrug Quality Assurance2019-11-07
- NAIDrug Quality Assurance2016-06-17
- NAIDrug Quality Assurance2014-02-11
- NAIDrug Quality Assurance2012-05-10
Drugs this plant is listed as making
6 distinct drugs across 36 products name this site in their FDA label.
- gadobenate dimeglumineBracco Diagnostics Inc
- GadopiclenolBracco Diagnostics Inc
- gadoteridolBracco Diagnostics Inc
- Iomeprol InjectionBIPSO GmbH
- IopamidolBracco Diagnostics 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.