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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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M Dialysis AB

Issue Date

Mar 13, 2014

Category

Device

Region

HQ
Investigator(s): Stephen D. Eich
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Mani Hanoi Co., Ltd.

Issue Date

Mar 20, 2014

Category

Device

Region

HQ
Investigator(s): Amy M. Cramer
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Thermogram Assessment Services

Issue Date

Dec 06, 2018

Category

Device

Region

Southwest
Investigator(s): Jeremy L. Stukes
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Alba Bioscience, Ltd.

Issue Date

Sep 14, 2018

Category

Device

Region

HQ
Investigator(s): Michele L. Forster
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Johnson Memorial Cancer Center

Issue Date

Oct 19, 2018

Category

Drug

Region

Northeast
Investigator(s): Erik W. Koester, John P. Mistler
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Dario D. Altamirano

Issue Date

Sep 21, 2018

Category

Clinical

Region

Southeast
Investigator(s): Angelica M. Chica
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Celestino P. Castellon

Issue Date

Aug 30, 2018

Category

Clinical

Region

Southeast
Investigator(s): Craig A. Garmendia
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ULTRAtab Laboratories, Inc.

Issue Date

Sep 14, 2018

Category

Drug

Region

Northeast
Investigator(s): Mindy M. Chou
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Westlab Pharmacy, Inc.

Issue Date

Aug 15, 2018

Category

Drug

Region

Southeast
Investigator(s): Jennifer L. Huntington
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Laboratorios Quantium LLC

Issue Date

Aug 02, 2018

Category

Drug

Region

Southeast
Investigator(s): Jennifer Lalama, Rozelle G. Smith
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Horizon Pharmaceuticals, Inc.

Issue Date

Aug 17, 2018

Category

Drug

Region

Southeast
Investigator(s): Jennifer Lalama, Shavon L. Square
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Debut Development, LLC

Issue Date

Sep 20, 2018

Category

Drug

Region

Southeast
Investigator(s): Jennifer Lalama
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