Drug factory · FDA FEI 3001686607

Cambrex Karlskoga AB

Bjorkborns Industriomrade, Karlskoga, Sweden

Sweden: 1

Problems found, fixed voluntarily at FDA's last inspection, May 24, 2024.

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: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Bupivacaine and MeloxicamMakes the active ingredient Heron Therapeutics, Inc. 47426-301, 47426-302, 47426-303 +5
RemimazolamMakes the active ingredient and tests it Acacia Pharma, Ltd. 71390-011

FDA inspection history

EndedResultProgramProblems noted
May 24, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 4, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 27, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 3, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.