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Zhejiang Huahai Pharmaceutical Co., Ltd. - Aug. 3, 2018

Issue Date

Aug 03, 2018

Region

HQ

Category

Drug
$117.00

Zhejiang Huahai Pharmaceutical Co., Ltd.

Contact Name

Jun Dun

Contact Title

Executive Vice President

Form483 Address 1

Coastal Industrial Zone, Chuannan No. 1 Branch

Form483 Address 2

Form483 City

Linhai, Zhejiang Province

Form483 State

Form483 Postal

317016

Form483 Country

China

Inspection Range

Jul 23, 2018 - Aug 03, 2018

Pages

11

First Observation

The change control system to evaluate all changes that may affect the production and control of intermediates or Active Pharmaceutical Ingredients (APIs) is not adequate.
Investigator(s): Cheryl Clausen, Joel D. Hustedt