Drug factory · FDA FEI 3005403245

Sandoz Industrial Products S.A

CALLE GORG MOLI D'EN PUIGVERD, 37 - 41, PG MAS PUIGVERD, Palafolls, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 21, 2022.

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

What it does, for whom

DrugRoleForNDC
AmpicillinMakes the active ingredient H.J. Harkins Co., Inc. 52959-389

FDA inspection history

EndedResultProgramProblems noted
Jul 21, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
May 17, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 10, 2015No problems foundDrug Quality Assurance—
Sep 25, 2013No problems foundDrug Quality Assurance—
Mar 12, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 11, 2009No problems foundDrug Quality Assurance—

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