483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device

Search By Company

Search By Region

Search By Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Zhejiang Huahai Pharmaceutical Co., Ltd. - May 15, 2017

Issue Date

May 19, 2017

Region

HQ

Category

Drug
$117.00

Zhejiang Huahai Pharmaceutical Co., Ltd.

Contact Name

Jun Du

Contact Title

Executive Vice President

Form483 Address 1

Coastal Industrial Zone

Form483 Address 2

Chuannan No. 1 Branch

Form483 City

Duqiao, Linhai Zhejiang

Form483 State

Form483 Postal

317016

Form483 Country

China

Inspection Range

May 15, 2017 - May 19, 2017

Pages

5

First Observation

Appropriate controls are not implemented over Quality Control instruments to ensure the integrity of analytical testing. Furthermore, anomalies in analytical testing are not investigated.
Investigator(s): Massoud Motamed