Drug factory · FDA FEI 3004762406

NerPharMa S.r.l

Via Louis Pasteur 10, Nerviano, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 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 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Arsenic Cation (3+)Makes it, makes the active ingredient, tests it and packages it Fresenius Kabi, LLC 63323-637
EribulinMakes it and tests it Eisai Inc. 62856-389
FludarabineMakes it Areva Pharmaceuticals, Inc., Lannett Company, Inc. 59923-604, 0527-1242
PhentolamineMakes it Precision Dose Inc. 68094-101
TemozolomideMakes it Areva Pharmaceuticals, Inc. 59923-703, 59923-704, 59923-705 +8
ThiotepaTests it Amneal Pharmaceuticals LLC 70121-2749

FDA inspection history

EndedResultProgramProblems noted
Sep 13, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 17, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 1, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 5, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 12, 2012No problems foundDrug Quality Assurance—
Jul 19, 2010No problems foundDrug Quality Assurance—
Oct 30, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

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