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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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Parts Precision Sweden AB

Issue Date

May 12, 2015

Category

Device

Region

HQ
Investigator(s): Edward R. Kay
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MED-EL Elektromedizinische Gereate, Gmbh

Issue Date

May 07, 2015

Category

Device

Region

HQ
Investigator(s): Raffi B. Papazian
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IT-V Medizintechnik GmbH

Issue Date

May 20, 2015

Category

Device

Region

HQ
Investigator(s): Cheryl D. McCall
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Mark R. Ryser

Issue Date

Sep 18, 2018

Category

Clinical

Region

Southwest
Investigator(s): Stephen T. Hansen, Dawn C. Olenjack, Theressa B. Smith
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HomeChoice Partners, Inc.

Issue Date

Sep 19, 2018

Category

Drug

Region

Southwest
Investigator(s): Tiara N. Brown-Crosen
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PharmScript, LLC

Issue Date

Aug 07, 2018

Category

Drug

Region

Central
Investigator(s): Sena G. Dissmeyer, Russell Glapion
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Wyeth Pharmaceuticals Co. dba Pfizer Consumer Healthcare

Issue Date

Aug 17, 2018

Category

Drug

Region

Southeast
Investigator(s): Jose Velez
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Baxter Healthcare of Puerto Rico

Issue Date

Aug 17, 2018

Category

Drug

Region

Southeast
Investigator(s): Noreen Muniz
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Amgen Manufacturing Ltd.

Issue Date

Aug 06, 2018

Category

Drug

Region

Southeast
Investigator(s): Vilmary Negron Rodriguez
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Sharp Drugs, Inc.

Issue Date

Jul 13, 2018

Category

Drug

Region

Northeast
Investigator(s): Nancy F. Scheraga
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P&L Developments, LLC

Issue Date

Sep 26, 2018

Category

Drug

Region

Pacific
Investigator(s): Truong Nguyen
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Neutraderm, Inc.

Issue Date

Sep 14, 2018

Category

Drug

Region

Pacific
Investigator(s): Andrew Haack
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