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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

Hisun Pharmaceutical (Hangzhou) Co., Ltd.

Issue Date

Apr 10, 2019

Category

Drug

Region

HQ
Investigator(s): Marijo B. Kambere
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Placeholderbook

Baxter Healthcare Pty Ltd.

Issue Date

Apr 09, 2019

Category

Drug

Region

HQ
Investigator(s): Jose A. Cruz-Gonzalez
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Respire Medical Holdings, LLC

Issue Date

Aug 15, 2019

Category

Device

Region

Northeast
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CooperSurgical, Inc.

Issue Date

Aug 01, 2019

Category

Device

Region

Northeast
Investigator(s): Nancy M. Espinal, Matthew D. Schnittker
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Med-Tex, LLC dba Med Textile

Issue Date

Jul 18, 2019

Category

Device

Region

Central
Investigator(s): Tiki J. Dixon
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Modulated Imaging, Inc.

Issue Date

May 24, 2019

Category

Device

Region

Pacific
Investigator(s): Kelvin Cheung
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Beth E. Safirstein

Issue Date

Aug 06, 2019

Category

Clinical

Region

Southeast
Investigator(s): Traci M. Armand
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Ryan M. Rich

Issue Date

Jul 29, 2019

Category

Clinical

Region

Southwest
Investigator(s): Theressa B. Smith
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Torrent Pharmaceuticals Ltd.

Issue Date

Apr 16, 2019

Category

Drug

Region

HQ
Investigator(s): Jogy George, Lata C. Mathew, Zhao Wang
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Placeholderbook

Zhejiang Tianyu Pharmaceutical Co., Ltd.

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Laurimer Kuilan-Torres
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Placeholderbook

Suzhou Homesum Pharmaceutical Co. Ltd.

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Vilmary Negron Rodriguez
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Placeholderbook

Jilin Asymchem Laboratories Co., Ltd.

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Christopher S. Keating
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