Drug factory · FDA FEI 3006339887

FUJIFILM Diosynth Biotechnologies Denmark ApS

Biotek Alle 1, Hillerod, Denmark

Denmark: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 30, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AmivantamabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-501
DaratumumabMakes the active ingredient Janssen Biotech, Inc. 57894-505
Daratumumab and Hyaluronidase (human Recombinant)Makes the active ingredient Janssen Biotech, Inc. 57894-503

FDA inspection history

EndedResultProgramProblems noted
Jun 30, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
May 10, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 16, 2017No problems foundDrug Quality Assurance—
Aug 19, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 27, 2011No problems foundDrug Quality Assurance—

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