Rechon Life Science AB
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
- Sweden
- Registered address
- Soldattorpsvagen 5, Limhamn, SE- 216 13, Sweden (SWE)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002806978 · DUNS 775207769
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 3 drugs, 1 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2024-09-06
- VAIDrug Quality Assurance2019-11-27
- VAIDrug Quality Assurance2018-06-29
- VAIDrug Quality Assurance2016-04-29
- VAIDrug Quality Assurance2014-03-21
- VAIDrug Quality Assurance2011-09-16
Drugs this plant is listed as making
3 distinct drugs across 9 products name this site in their FDA label.
- anakinraSwedish Orphan Biovitrum AB (publ)
- Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtlBioverativ Therapeutics Inc.
- Desmopressin Acetatein shortageNordic Pharma, 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.