Drug factory · FDA FEI 3008705620

Esteve Huayi Pharmaceutical Co., Ltd.

Linhai Rd., Yuecheng District, Shaoxing, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 14, 2025.

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 2012: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BrensocatibMakes the active ingredient and tests it Insmed Incorporated 71558-001, 71558-002

FDA inspection history

EndedResultProgramProblems noted
Mar 14, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 23, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 20, 2015No problems foundDrug Quality Assurance—
Jan 6, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.