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Livzon Group Fuzbou Fuxing Pharmaceutical Co. Ltd. - Aug. 3, 2018

Issue Date

Aug 03, 2018

Region

HQ

Category

Drug
$117.00

Livzon Group Fuzbou Fuxing Pharmaceutical Co. Ltd.

Contact Name

Weimin Wang

Contact Title

General Manager

Form483 Address 1

Jiangyin Industrial Development Zone

Form483 Address 2

Form483 City

Fuqing, Fujian Province

Form483 State

Form483 Postal

350309

Form483 Country

China

Inspection Range

Jul 30, 2018 - Aug 03, 2018

Pages

2

First Observation

Failure to ensure … used in the final manufacturing steps of a non-sterile API either intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.
Investigator(s): Santos E. Camara, Nicole E. Knowlton