Drug factory · FDA FEI 3008250362

Qilu Pharmaceutical (Hainan) Co., Ltd.

No.273-A, Nanhai Avenue, National High-Tech Zone, Haikou, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, May 19, 2023.

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

5 drug inspections on record since 2014: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AprepitantMakes it and tests it Qilu Pharmaceutical Co., Ltd. 67184-0540
BortezomibMakes it and tests it BluePoint Laboratories., Qilu Pharmaceutical Co., Ltd. 68001-540, 67184-0530
BumetanideMakes it and tests it Mullan Pharmaceutical Inc., Qilu Pharmaceutical Co., Ltd. 83301-0080, 83301-0081, 67184-0593 +1
DaptomycinMakes it and tests it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-6229, 67184-0549
DecitabineMakes it, tests it and packages it BluePoint Laboratories., Qilu Pharmaceutical Co., Ltd. 68001-618, 67184-0535
DoxorubicinMakes it, tests it and packages it Qilu Pharmaceutical Co., Ltd. 67184-0623, 67184-0624
GefitinibMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC, Qilu Pharmaceutical Co., Ltd. 50742-366, 67184-0531
IfosfamideMakes it SteriMax Inc. 21586-211
ImatinibMakes it, tests it and packages it Archis Pharma LLC, Qilu Pharmaceutical Co., Ltd., Upsher-Smith Laboratories, Inc. 72819-185, 72819-186, 67184-0532 +3
IrinotecanMakes it, tests it and labels it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-6128, 60505-6272, 67184-0511 +2
MelphalanMakes it and tests it Qilu Pharmaceutical Co., Ltd. 67184-0618
MicafunginMakes it and tests it Glenmark Pharmaceuticals Inc., USA, Qilu Pharmaceutical Co., Ltd. 68462-771, 68462-772, 67184-0589 +1
NicardipineMakes it and tests it Qilu Pharmaceutical Co., Ltd. 67184-0611
OndansetronMakes it and tests it Apotex Corp., Qilu Pharmaceutical Co., Ltd. 60505-4939, 60505-6130, 67184-0507
OxaliplatinMakes it and tests it Apotex Corp., BluePoint Laboratories., Nextgen Pharmaceuticals LLC, Qilu Pharmaceutical Co., Ltd. 60505-6132, 60505-6287, 68001-468 +7
PalonosetronMakes it, tests it and packages it Apotex Corp., BluePoint Laboratories., Qilu Pharmaceutical Co., Ltd. 60505-6193, 60505-6439, 68001-708 +2
PemetrexedMakes it, tests it, packages it and labels it BluePoint Laboratories., Qilu Pharmaceutical Co., Ltd. 68001-538, 68001-539, 67184-0503 +1
TadalafilMakes it, tests it and packages it Qilu Pharmaceutical Co., Ltd., Upsher-Smith Laboratories, Inc. 67184-0523, 67184-0524, 67184-0525 +5

FDA inspection history

EndedResultProgramProblems noted
May 19, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 6, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 17, 2017No problems foundDrug Quality Assurance—
Aug 2, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
May 23, 2014Problems found, fixed voluntarilyDrug Quality Assurance—

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