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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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Ortho Clinical Diagnostics

Issue Date

May 10, 2019

Category

Device

Region

Central
Investigator(s): Matthew D. Schnittker
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Accord Media, LLC

Issue Date

May 13, 2019

Category

Device

Region

Central
Investigator(s): Ronald Ifraimov
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Zavation Medical Products, LLC

Issue Date

Jun 20, 2019

Category

Device

Region

Southeast
Investigator(s): Nicholas Z. Lu
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Emilia Resources, LLC

Issue Date

Jun 18, 2019

Category

Device

Region

Southeast
Investigator(s): Nicholas Z. Lu
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The Lebanon Corp., Inc.

Issue Date

Jun 28, 2019

Category

Device

Region

Central
Investigator(s): Debara R. Reese
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Truemed Group, LLC

Issue Date

Jun 05, 2019

Category

Device

Region

Southwest
Investigator(s): Jocelyn C. Turner
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Medco Manufacturing

Issue Date

May 13, 2019

Category

Device

Region

Southwest
Investigator(s): Jocelyn C. Turner
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Acuity Surgical Devices, LLC

Issue Date

May 29, 2019

Category

Device

Region

Southwest
Investigator(s): Jeremy L. Stukes
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American Bio Medica Corp.

Issue Date

Jun 13, 2019

Category

Device

Region

Central
Investigator(s): Tiki J. Dixon
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Anil C. Odhav

Issue Date

Jun 10, 2019

Category

Clinical

Region

Southwest
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Muhammad Salman Ali Ashraf

Issue Date

May 16, 2019

Category

Clinical

Region

Central
Investigator(s): Kathryn Suttling
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Northland Nuclear Medicine, LLC

Issue Date

Jun 07, 2019

Category

Drug

Region

Central
Investigator(s): Scott A. Golladay, Anthony J. Ladner
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