Drug factory · FDA FEI 3003418999

Patheon Biologics LLC

4766 LaGuardia Drive, Saint Louis, MO, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 20, 2024.

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

7 drug inspections on record since 2010: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
LerodalcibepMakes the active ingredient LIB Therapeutics, Inc. 84685-300
Olipudase AlfaMakes the active ingredient and tests it Genzyme Corporation 58468-0050, 58468-0051

FDA inspection history

EndedResultProgramProblems noted
Nov 20, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 8, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 2, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 2, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 21, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 3, 2012No problems foundDrug Quality Assurance—
Jun 23, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.