Drug factory · FDA FEI 3003999190

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao Town, Linhai, China

China: 1

Serious problems, FDA action at FDA's last inspection, Apr 24, 2026.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

8 drug inspections on record since 2010: 4 with no problems, 1 with problems fixed voluntarily, 3 with FDA action.

What it does, for whom

DrugRoleForNDC
AripiprazoleMakes it Solco Healthcare U.S., LLC 43547-302, 43547-303, 43547-304 +3
BenazeprilatMakes it International Laboratories, LLC 54458-862, 54458-863
DoxycyclineMakes it Solco Healthcare U.S., LLC 43547-324, 43547-325, 43547-462 +1
EnalaprilatMakes it Solco Healthcare U.S., LLC 43547-545, 43547-546, 43547-547 +1
EntecavirMakes it Solco Healthcare U.S., LLC 43547-436, 43547-437
EscitalopramMakes it BluePoint Laboratories. 68001-591, 68001-592, 68001-593
EsomeprazoleMakes it Solco Healthcare U.S., LLC 43547-001, 43547-002
FingolimodMakes it Solco Healthcare U.S., LLC 43547-003
Hydrochlorothiazide and LosartanMakes it Solco Healthcare U.S., LLC 43547-423, 43547-424, 43547-425
Hydrochlorothiazide and OlmesartanMakes it Solco Healthcare U.S., LLC 43547-391, 43547-392, 43547-393
Hydrochlorothiazide and ValsartanMakes it Solco Healthcare U.S., LLC 43547-311, 43547-312, 43547-313 +2
IrbesartanMakes it Solco Healthcare U.S., LLC 43547-374, 43547-375, 43547-376
LevetiracetamMakes it Solco Healthcare U.S., LLC 43547-454
LisinoprilMakes it and makes the active ingredient Ranbaxy Laboratories Inc. 63304-531, 63304-532, 63304-533 +3
MetforminMakes it Solco Healthcare U.S., LLC 43547-503, 43547-504
NebivololMakes it Solco Healthcare U.S., LLC 43547-524, 43547-525, 43547-526 +1
OlmesartanMakes it Solco Healthcare U.S., LLC 43547-299, 43547-300, 43547-301
ParoxetineMakes it Solco Healthcare U.S., LLC 43547-347, 43547-348, 43547-349 +2
PemetrexedMakes it Solco Healthcare U.S., LLC 43547-632
PregabalinMakes it Solco Healthcare U.S., LLC 43547-506, 43547-507, 43547-508 +5
QuetiapineMakes it Solco Healthcare U.S., LLC 43547-019, 43547-020, 43547-021 +8
QuinaprilatMakes it Solco Healthcare U.S., LLC 43547-410, 43547-411, 43547-412 +1
RocuroniumMakes it Solco Healthcare U.S., LLC 43547-530, 43547-531
RoflumilastMakes it Solco Healthcare U.S., LLC 43547-005
RopiniroleMakes it Solco Healthcare U.S., LLC 43547-554, 43547-555, 43547-556 +2
TadalafilMakes it Solco Healthcare U.S., LLC 43547-047, 43547-049, 43547-050 +2
TelmisartanMakes it Solco Healthcare U.S., LLC 43547-283, 43547-284, 43547-285
TicagrelorMakes it Solco Healthcare U.S., LLC 43547-657
VoriconazoleMakes it Solco Healthcare U.S., LLC 43547-377, 43547-378

FDA inspection history

EndedResultProgramProblems noted
Apr 24, 2026Serious problems, FDA actionDrug Quality Assurance—
Jan 24, 2025Serious problems, FDA actionDrug Quality Assurance—
Jul 2, 2021No problems foundDrug Quality Assurance—
May 31, 2019Serious problems, FDA actionDrug Quality Assurance—
Nov 18, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 27, 2015No problems foundDrug Quality Assurance—
Aug 9, 2013No problems foundDrug Quality Assurance—
Sep 2, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture; manufacture.