Drug factory · FDA FEI 3006704412

Shandong New Time Pharmaceutical Co., Ltd.

No. 1, North Outer Ring Road, Feixian, Linyi, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 9, 2024.

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

4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
IsofluraneMakes it Mullan Pharmaceutical Inc., Shandong New Time Pharmaceutical Co., Ltd. 83301-0071, 83301-0072, 42677-326 +1
Isosorbide MononitrateMakes it AiPing Pharmaceutical, Inc., Shandong New Time Pharmaceutical Co., Ltd. 11788-159, 11788-160, 11788-161 +3
MilrinoneMakes it Mullan Pharmaceutical Inc., Shandong New Time Pharmaceutical Co., Ltd. 83301-0016, 83301-0017, 83301-0018 +3
Oseltamivir AcidMakes it Shandong New Time Pharmaceutical Co., Ltd. 42677-320, 42677-321, 42677-322
OxaliplatinMakes it Shandong New Time Pharmaceutical Co., Ltd. 42677-336, 42677-337
RocuroniumMakes it Shandong New Time Pharmaceutical Co., Ltd. 42677-309, 42677-310
RosuvastatinMakes it Shandong New Time Pharmaceutical Co., Ltd. 42677-301, 42677-302, 42677-303 +1
SevofluraneMakes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it Lannett Company, Inc., Mullan Pharmaceutical Inc., NextSource Biotechnology, LLC, Shandong New Time Pharmaceutical Co., Ltd. 0527-6123, 83301-0070, 58181-5200 +1
SugammadexMakes it Mullan Pharmaceutical Inc., Shandong New Time Pharmaceutical Co., Ltd. 83301-0077, 83301-0078, 42677-311 +1

FDA inspection history

EndedResultProgramProblems noted
Jul 9, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
May 11, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 25, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 23, 2013Problems found, fixed voluntarilyDrug Quality Assurance—

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