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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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Brian J. Byrne

Issue Date

Feb 22, 2019

Category

Clinical

Region

Northeast
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Unither Manufacturing, LLC.

Issue Date

May 22, 2019

Category

Drug

Region

Northeast
Investigator(s): Niketa Patel
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Evaric Pharmaceuticals, Inc.

Issue Date

May 29, 2019

Category

Drug

Region

Northeast
Investigator(s): Jay T. Wong
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Ipsen Bioscience, Inc.

Issue Date

Feb 26, 2019

Category

Drug

Region

Northeast
Investigator(s): Robert J. Martin
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Mayo Clinic PET Radiochemistry Facility

Issue Date

Apr 12, 2019

Category

Drug

Region

Southeast
Investigator(s): Libia Lugo
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Velocity Production and Packaging

Issue Date

May 08, 2019

Category

Drug

Region

Pacific
Investigator(s): Erika V. Butler
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Sandoz Inc.

Issue Date

Apr 16, 2019

Category

Drug

Region

Southwest
Investigator(s): Erika V. Butler
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Total Vein Pharmacy, LLC

Issue Date

May 09, 2019

Category

Drug

Region

Southwest
Investigator(s): Stephen D. Brown
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Cytovance Biologics, Inc.

Issue Date

May 19, 2019

Category

Drug

Region

Southwest
Investigator(s): Margaret M. Annes
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Custom Compounding Center

Issue Date

Jun 04, 2019

Category

Drug

Region

Southwest
Investigator(s): Jason Caballero
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Synthetopes, Inc.

Issue Date

May 16, 2019

Category

Drug

Region

Southeast
Investigator(s): Jessica Pressley
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LPE Holdings, LLC

Issue Date

Apr 17, 2019

Category

Device

Region

Pacific
Investigator(s): Paul M. Kawamoto
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