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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.

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Shire Human Genetic Therapies, Inc.

Issue Date

Feb 01, 2018

Category

Drug

Region

Northeast
Investigator(s): Sean R. Marcsisin, Edmund F. Mrak
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Placeholderbook

Teligent, Inc.

Issue Date

Oct 19, 2017

Category

Drug

Region

Central
Investigator(s): Nancy M. Espinal
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Ecolab, Inc.

Issue Date

Nov 09, 2018

Category

Drug

Region

Central
Investigator(s): Sarah E. Rhoades
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Home Choice Partners, Inc.

Issue Date

Aug 17, 2018

Category

Drug

Region

Southeast
Investigator(s): Tamara J. Henderson, Johnetta F. Walters
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Placeholderbook

Winder Laboratories, LLC

Issue Date

Jul 18, 2018

Category

Drug

Region

Southeast
Investigator(s): Robert J. Martin
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Placeholderbook

F.P. Rubinstein Y Cia SRL

Issue Date

Dec 17, 2015

Category

Device

Region

HQ
Investigator(s): Marc S. Neubauer
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Placeholderbook

ab medical s.a.s.

Issue Date

Dec 10, 2015

Category

Device

Region

HQ
Investigator(s): Gamal A. Norton
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Summit Medical, Ltd.

Issue Date

Aug 05, 2015

Category

Device

Region

HQ
Investigator(s): James M. O'Donnell
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Shenzhen Creative Industry Co., Ltd.

Issue Date

Aug 06, 2015

Category

Device

Region

HQ
Investigator(s): Catherine J. Laufmann
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Placeholderbook

Lanterna Medical Technologies GMBH

Issue Date

Aug 13, 2015

Category

Device

Region

HQ
Investigator(s): Tania E. Vizcaino
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Placeholderbook

Anna Kostera-Pruszczyk

Issue Date

Jul 13, 2018

Category

Clinical

Region

HQ
Investigator(s): Sunitha K. Rajaram
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Placeholderbook

MSD International GmbH

Issue Date

Oct 12, 2018

Category

Drug

Region

HQ
Investigator(s): Jose A. Cruz-Gonzalez
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