SGS Institut Fresenius 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
- Tegeler Weg 33, Berlin, 10589, Germany (DEU)
- Operations here
- analysis
- FDA identifiers
- FEI 3004908885 · DUNS 341259550
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-11-23
- NAIDrug Quality Assurance2019-06-17
- NAIDrug Quality Assurance2017-01-27
- NAIDrug Quality Assurance2014-05-09
- VAIDrug Quality Assurance2012-04-27
- VAIDrug Quality Assurance2010-10-19
Drugs this plant is listed as making
3 distinct drugs across 13 products name this site in their FDA label.
- deferoxamine mesylateMitem Pharma
- Prussian blue insoluble capsulesHeyl Chem.-pharm. Fabrik GmbH & Co. KG
- SelexipagActelion Pharmaceuticals US, 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.