Drug factory · FDA FEI 3002807748

Novo Nordisk A/S - Hax

Hagedornsvej 1, Gentofte, Denmark

Denmark: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 1, 2023.

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

6 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CatridecacogMakes it and makes the active ingredient Novo Nordisk 0169-7013
Coagulation Factor Viia Recombinant HumanMakes it Novo Nordisk 0169-7010, 0169-7020, 0169-7040 +5
SomatropinMakes it and makes the active ingredient Novo Nordisk 0169-7703, 0169-7704, 0169-7705 +1

FDA inspection history

EndedResultProgramProblems noted
Jun 1, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
May 8, 2018No problems foundDrug Quality Assurance—
Jun 14, 2016No problems foundDrug Quality Assurance—
May 13, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 26, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 6, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

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