Drug factory · FDA FEI 3003802432

Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)

No.317, Xinluo Road, High-tech Zone, Jinan, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 14, 2025.

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 2013: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CefazolinMakes it, tests it, packages it and labels it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-6142, 60505-6143, 60505-6231 +5
CefepimeMakes it, tests it, packages it and labels it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-6144, 60505-6145, 60505-6146 +6
CeftriaxoneMakes it, tests it, packages it and labels it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-6148, 60505-6149, 60505-6150 +6
CyclosporineMakes it, tests it and packages it Qilu Pharmaceutical Co., Ltd., Upsher-Smith Laboratories, Inc. 67184-0584, 67184-0585, 24979-126
IcosapentMakes it and tests it Qilu Pharmaceutical Co., Ltd. 67184-0582
OlanzapineMakes it, tests it and packages it Qilu Pharmaceutical Co., Ltd. 67184-0561, 67184-0562, 67184-0563 +3
SolifenacinMakes it and packages it Apotex Corp. 60505-4702, 60505-4703
TenofovirMakes it and packages it Florida Pharmaceutical Products, LLC., Qilu Pharmaceutical Co., Ltd. 69076-105, 71921-105, 67184-0519 +2

FDA inspection history

EndedResultProgramProblems noted
Jan 14, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 27, 2019No problems foundDrug Quality Assurance—
Apr 17, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 20, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 19, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 18, 2013Problems found, fixed voluntarilyDrug Quality Assurance—

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