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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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Evergreen Orthopedic Research Lab, LLC

Issue Date

Apr 12, 2019

Category

Device

Region

Pacific
Investigator(s): Christopher S. Genther
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Comfort Acrylics, Inc.

Issue Date

Apr 19, 2019

Category

Device

Region

Pacific
Investigator(s): Paul M. Kawamoto
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Bio- Med Diagnostics, Inc.

Issue Date

Apr 19, 2019

Category

Device

Region

Pacific
Investigator(s): Stephen R. Souza
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R.E.C. Manufacturing Corp.

Issue Date

Feb 26, 2019

Category

Device

Region

Northeast
Investigator(s): Sara M. Richardson
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PF Consumer Healthcare 1, LLC

Issue Date

Apr 01, 2019

Category

Device

Region

Southeast
Investigator(s): Dawn M. Braswell, Joshua J. Silvestri, Lisa A. Warner
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Memtec Corp.

Issue Date

Feb 04, 2019

Category

Device

Region

Northeast
Investigator(s): James W. Whitney
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Madison Polymeric Engineering

Issue Date

Feb 22, 2019

Category

Device

Region

Northeast
Investigator(s): Michael G. Mayfield
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Globus Medical, Inc.

Issue Date

Feb 13, 2019

Category

Device

Region

Northeast
Investigator(s): Justine Corson
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Convexity Scientific, Inc.

Issue Date

Feb 08, 2019

Category

Device

Region

Northeast
Investigator(s): Michael G. Mayfield
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Robert L. Sufit

Issue Date

Mar 04, 2019

Category

Clinical

Region

Central
Investigator(s): Shalonda C. Clifford
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Sarah D. Atkinson

Issue Date

Apr 27, 2018

Category

Clinical

Region

Northeast
Investigator(s): Benton M. Ketron
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LNK International, Inc.

Issue Date

Feb 08, 2019

Category

Drug

Region

Northeast
Investigator(s): Guerlain Ulysse
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