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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

Madhukar H. Trivedi

Issue Date

Jan 11, 2019

Category

Clinical

Region

Southwest
Investigator(s): Camille D. Brown, Mathew T. Thomas
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Placeholderbook

Julian J. Gonzalez

Issue Date

Jan 16, 2019

Category

Clinical

Region

Southwest
Investigator(s): Leighton K. Ngai
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Unither Manufacturing LLC

Issue Date

Dec 21, 2018

Category

Drug

Region

Northeast
Investigator(s): Yvesna Blaise
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Kingston Pharma LLC

Issue Date

Dec 10, 2018

Category

Drug

Region

Northeast
Investigator(s): Edmund F. Mrak
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Eisai, Inc.

Issue Date

Jul 22, 2016

Category

Drug

Region

Central
Investigator(s): Eric L. Dong, Qin Xu
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InvaGen Pharmaceuticals, Inc.

Issue Date

Dec 19, 2018

Category

Drug

Region

Northeast
Investigator(s): Jose O. Hernandez
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Advance Pharmaceutical, Inc.

Issue Date

Dec 13, 2018

Category

Drug

Region

Northeast
Investigator(s): Sony Mathews
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Leading Phanna, LLC

Issue Date

Jan 31, 2019

Category

Drug

Region

Central
Investigator(s): Tonia Bernard
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Pharmacy Resources Inc.

Issue Date

Jan 29, 2019

Category

Drug

Region

Southwest
Investigator(s): Linda F. Murphy
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SOFIE Co.

Issue Date

Jan 15, 2019

Category

Drug

Region

Southwest
Investigator(s): Patty Kaewussdangkul
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Placeholderbook

3D Imaging Drug Design and Development

Issue Date

Jan 18, 2019

Category

Drug

Region

Southwest
Investigator(s): Margaret M. Annes
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Placeholderbook

Eisai, Inc.

Issue Date

Sep 13, 2013

Category

Drug

Region

Southeast
Investigator(s): Bonita S. Chester, Tsedenia Woldehanna
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