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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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Newman Medical

Issue Date

May 31, 2019

Category

Device

Region

Southwest
Investigator(s): Vicky L. Cruz
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Placeholderbook

Key Distributed Products dba Advanced Vision Technologies, Inc.

Issue Date

May 10, 2019

Category

Device

Region

Southwest
Investigator(s): Matthew M. Vernon
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ICU Medical, Inc.

Issue Date

Apr 04, 2019

Category

Device

Region

Southwest
Investigator(s): James R. Montero
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CoRE Labs, LLC

Issue Date

Apr 11, 2019

Category

Device

Region

Southwest
Investigator(s): Vicky L. Cruz
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CellEra, LLC

Issue Date

May 30, 2019

Category

Device

Region

Central
Investigator(s): Teresa K. Kastner
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Theragen, Inc.

Issue Date

May 23, 2019

Category

Device

Region

Central
Investigator(s): Tiki J. Dixon
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Tram K. Tran-Johnson

Issue Date

Feb 01, 2019

Category

Clinical

Region

Pacific
Investigator(s): Marilyn S. Babu, Ni A. Khin, Diane C. Van Leeuwen
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Stuart L. Silverman

Issue Date

Feb 01, 2019

Category

Clinical

Region

Pacific
Investigator(s): Sunitha K. Rajaram
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Kyowa Hakka Kirin Co.

Issue Date

Dec 11, 2018

Category

Drug

Region

HQ
Investigator(s): Dennis Cantellops
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Ingenus Pharmaceuticals GmbH

Issue Date

Dec 11, 2018

Category

Drug

Region

HQ
Investigator(s): Yasamin Ameri
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Mylan Laboratories Ltd.

Issue Date

Dec 10, 2018

Category

Drug

Region

HQ
Investigator(s): Darren S. Brown, Nayan J. Patel
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Swabplus, L.P.

Issue Date

Apr 11, 2019

Category

Drug

Region

Pacific
Investigator(s): Diane R. Weidley, Marcus F. Yambot
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