Drug factory · FDA FEI 3007992266

Catalent Micron Technologies, Inc.

333 Phoenixville Pike, Malvern, PA, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 9, 2025.

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: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AmifampridineTests it and mills it Catalyst Pharmaceuticals, Inc. 69616-211
BelumosudilTests it Kadmon Pharmaceuticals, LLC 79802-200
VandetanibTests it and mills it Genzyme Corporation 58468-7820, 58468-7840

FDA inspection history

EndedResultProgramProblems noted
Jun 9, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2019No problems foundDrug Quality Assurance—
Apr 20, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 12, 2013No problems foundDrug Quality Assurance—
Dec 8, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 31, 2010No problems foundDrug Quality Assurance—
Feb 23, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; particle size reduction.