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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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AcousticSheep, LLC

Issue Date

Nov 06, 2018

Category

Device

Region

Central
Investigator(s): Katelyn A. Staub-Zamperini
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Follett, LLC

Issue Date

Oct 25, 2018

Category

Device

Region

Central
Investigator(s): Brian S. Keefer
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Heidi J. Gray

Issue Date

Nov 16, 2018

Category

Clinical

Region

Pacific
Investigator(s): Sunitha K. Rajaram
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Charles J. Parker

Issue Date

Jan 18, 2019

Category

Clinical

Region

Southwest
Investigator(s): Stephen T. Hansen
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Epien Medical, Inc.

Issue Date

Dec 06, 2018

Category

Drug

Region

Central
Investigator(s): James K. Ireland
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Antares Pharma, Inc.

Issue Date

Dec 04, 2018

Category

Drug

Region

Central
Investigator(s): Susan M. Matthias
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3M Company

Issue Date

Jan 25, 2019

Category

Drug

Region

Central
Investigator(s): Anthony J. Ladner, Victoria A. Wagoner
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Siddha Flower Essences LLC

Issue Date

Dec 12, 2018

Category

Drug

Region

Pacific
Investigator(s): Christopher M. Jenner
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Panrosa Enterprise, Inc.

Issue Date

Dec 18, 2018

Category

Drug

Region

Pacific
Investigator(s): Bryan A. Galvez
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Septodont, Inc.

Issue Date

Dec 21, 2018

Category

Drug

Region

Southwest
Investigator(s): Jamie L. Dion
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Tris Pharma, Inc.

Issue Date

Jan 23, 2019

Category

Drug

Region

Central
Investigator(s): Tamil Arasu, Russell Glapion, Jose O. Hernandez
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Hamamatsu/Queens PET Imaging Center, LLC

Issue Date

Dec 13, 2018

Category

Drug

Region

Pacific
Investigator(s): Zachary A. Bogorad, Kenneth O. Gee, Nicholas L. Hunt
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