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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.

Placeholderbook

Stefan w. Kreuzer

Issue Date

Aug 13, 2019

Category

Clinical

Region

Southwest
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Placeholderbook

Richard M. Evans

Issue Date

Aug 19, 2019

Category

Clinical

Region

Southwest
Investigator(s): Johann M. Fitch
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Wuxi Biologics Co., Ltd.

Issue Date

Apr 16, 2019

Category

Drug

Region

HQ
Investigator(s): Mekonnon LemmaDechassa, Christopher T. Middendorf, Ramesh Potla
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Placeholderbook

Bloomage Biotechnology Corp., Ltd.

Issue Date

Apr 26, 2019

Category

Drug

Region

HQ
Investigator(s): Laurimer Kuilan-Torres
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Zenara Pharma Pvt., Ltd.

Issue Date

Apr 26, 2019

Category

Drug

Region

HQ
Investigator(s): Jason Caballero
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Placeholderbook

Hainan Shuangcheng Pharmaceuticals Co., Ltd.

Issue Date

Apr 24, 2019

Category

Drug

Region

HQ
Investigator(s): Jonathan Chapman
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Glenmark Pharmaceuticals, Ltd.

Issue Date

Apr 20, 2019

Category

Drug

Region

HQ
Investigator(s): Justin A. Boyd, Rita K. Kabaso
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Placeholderbook

Linhai Tianyu Pharmaceutical Co., Ltd.

Issue Date

Apr 19, 2019

Category

Drug

Region

HQ
Investigator(s): Joel D. Hustedt, Teresa I. Navas
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Placeholderbook

ANSTO Nuclear Medicine

Issue Date

Apr 17, 2019

Category

Drug

Region

HQ
Investigator(s): Jose A. Cruz-Gonzalez
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Teva API India Pvt., Ltd.

Issue Date

Apr 16, 2019

Category

Drug

Region

HQ
Investigator(s): Dipesh Shah, Rajiv R. Srivastava
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Placeholderbook

Sumitomo Dainippon Pharma Co., Ltd.

Issue Date

Apr 16, 2019

Category

Drug

Region

HQ
Investigator(s): Linda F. Murphy, Zhongren Wu
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Placeholderbook

Stickman Dialysis Industries, LLC

Issue Date

Aug 08, 2019

Category

Device

Region

Northeast
Investigator(s): James W. Whitney
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