483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA 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 Kangle Pharmaceutical Co., Ltd. - March 22, 2019

Issue Date

Mar 22, 2019

Region

HQ

Category

Drug
$117.00

Zhejiang Kangle Pharmaceutical Co., Ltd.

Contact Name

Yang XiaoMing

Contact Title

Vice President

Form483 Address 1

555 the 8th Binhai Rd.

Form483 Address 2

Econ and tech Dev Zone

Form483 City

Wenzhou, Zhejiang

Form483 State

Form483 Postal

325025

Form483 Country

China

Inspection Range

Mar 18, 2019 - Mar 22, 2019

Pages

2

First Observation

Equipment and Facilities system l. Procedures related to the security, integrity and control of cleaning documents associated with the production or (b) (4) - a furnished dose immediately distributed by your firm for further manufacture into solid forms are not followed.
Investigator(s): Christopher T. Middendorf