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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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Regi US, Inc.

Issue Date

Jan 15, 2019

Category

Drug

Region

Central
Investigator(s): Emmanuel J. Ramos
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Leading Pharma, 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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Baxter Healthcare Corp.

Issue Date

Dec 21, 2018

Category

Drug

Region

Southeast
Investigator(s): Laurimer Kuilan-Torres, Miguel A. Martinez, Jose E. Melendez
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Ingenue Care

Issue Date

Dec 06, 2018

Category

Drug

Region

Pacific
Investigator(s): Jolanna A. Norton
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Acuity Polymers, Inc.

Issue Date

Oct 09, 2018

Category

Device

Region

Northeast
Investigator(s): Matthew D. Schnittker
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US BioTek Laboratories, Inc.

Issue Date

Nov 14, 2018

Category

Device

Region

Pacific
Investigator(s): Stephen R. Souza
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Medstrat, Inc.

Issue Date

Nov 09, 2018

Category

Device

Region

Central
Investigator(s): Shafiq S. Ahadi
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Starkey Labs, Inc.

Issue Date

Nov 13, 2018

Category

Device

Region

Central
Investigator(s): Christina L. Bigham
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Hi Healthlnnovations

Issue Date

Nov 30, 2018

Category

Device

Region

Central
Investigator(s): Christina L. Bigham
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Taddese T. Desta

Issue Date

Nov 07, 2018

Category

Clinical

Region

Pacific
Investigator(s): Marilyn S. Babu, Angela Shepas
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Mercedes Samson

Issue Date

Nov 02, 2018

Category

Clinical

Region

Pacific
Investigator(s): Corey Reno
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