Drug factory · FDA FEI 3005183062

Zhejiang SyncoTide Bio-pharmaceutical Co., Ltd

Yuedong Road, Paojiang Industrial Zone, Shaoxing, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2025.

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 2010: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
QuetiapineMakes the active ingredient SpecGx LLC 0406-1180, 0406-1181, 0406-1182 +2

FDA inspection history

EndedResultProgramProblems noted
Mar 7, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 1, 2018No problems foundDrug Quality Assurance—
Mar 25, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 20, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 4, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.