Drug factory · FDA FEI 3002806978

Rechon Life Science AB

Soldattorpsvagen 5, Limhamn, Sweden

Sweden: 1

Serious problems, FDA action at FDA's last inspection, Sep 6, 2024.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

6 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
DesmopressinMakes it Nordic Pharma, Inc. 69918-899, 69918-901
Efanesoctocog AlfaPackages it and labels it Bioverativ Therapeutics Inc. 71104-978, 71104-979, 71104-981 +3
Eftrenonacog AlfaPackages it and labels it Bioverativ Therapeutics Inc. 71104-911, 71104-922, 71104-933 +3

FDA inspection history

EndedResultProgramProblems noted
Sep 6, 2024Serious problems, FDA actionDrug Quality Assurance—
Nov 27, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 29, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 16, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.