Drug factory · FDA FEI 3005115952

Hainan Poly Pharm. Co., Ltd.

Guilinyang Economic Development Zone, Meilan District, Haikou, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 30, 2023.

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 2014: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
4-HydroxycyclophosphamideMakes it Hainan Poly Pharm. Co., Ltd., Hisun Pharmaceuticals USA Inc., Slate Run Pharmaceuticals, LLC. 14335-470, 14335-471, 14335-472 +6
AzithromycinMakes it, tests it and packages it Slate Run Pharmaceuticals, LLC. 70436-019
BivalirudinMakes it Slate Run Pharmaceuticals, LLC. 70436-025
BrivaracetamMakes it and tests it Hainan Poly Pharm. Co., Ltd. 14335-420
CisatracuriumMakes it and makes the active ingredient Slate Run Pharmaceuticals, LLC. 70436-112, 70436-113, 70436-114
DaptomycinMakes it Hainan Poly Pharm. Co., Ltd., Sintetica US LLC, Slate Run Pharmaceuticals, LLC. 14335-120, 83090-011, 70436-033
DicyclomineMakes it, tests it and packages it Slate Run Pharmaceuticals, LLC. 70436-147
DobutamineMakes it, makes the active ingredient, tests it, packages it and labels it Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC. 14335-171, 14335-172, 70436-203
EptifibatideMakes it, tests it and packages it Slate Run Pharmaceuticals, LLC. 70436-026, 70436-027, 70436-162 +1
EsomeprazoleMakes it, makes the active ingredient, tests it and packages it Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC. 14335-060, 70436-190
Gadolinium Cation (3+)Makes it Slate Run Pharmaceuticals, LLC. 70436-123, 70436-212, 70436-213 +4
GadoteridolMakes it Slate Run Pharmaceuticals, LLC. 70436-121
IopamidolMakes it Slate Run Pharmaceuticals, LLC. 70436-124, 70436-125, 70436-126 +3
LacosamideMakes it, tests it and packages it Hainan Poly Pharm. Co., Ltd., Sintetica US LLC 14335-330, 83090-012
LeucovorinMakes it Slate Run Pharmaceuticals, LLC. 70436-116, 70436-117, 70436-118 +2
LevetiracetamMakes it, tests it, packages it and labels it Hainan Poly Pharm. Co., Ltd., Precision Dose Inc., TAGI Pharma, Inc. 14335-050, 68094-313, 51224-013
LevoleucovorinMakes it and tests it Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC. 14335-340, 14335-341, 70436-209 +1
LincomycinMakes it and makes the active ingredient Slate Run Pharmaceuticals, LLC. 70436-034, 70436-035
MethocarbamolMakes it Slate Run Pharmaceuticals, LLC. 70436-149
NitroprussideMakes it, makes the active ingredient, tests it and packages it Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC. 14335-132, 14335-133, 14335-134 +3
PhenylephrineMakes it Hainan Poly Pharm. Co., Ltd. 14335-440, 14335-441, 14335-442
TobramycinMakes it and makes the active ingredient Slate Run Pharmaceuticals, LLC. 70436-110
VancomycinMakes it and tests it Slate Run Pharmaceuticals, LLC. 70436-020, 70436-021, 70436-022 +1
VoriconazoleMakes it, tests it, packages it and labels it Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC. 14335-730, 70436-029

FDA inspection history

EndedResultProgramProblems noted
Jun 30, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 19, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 22, 2014Problems found, fixed voluntarilyDrug Quality Assurance—

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