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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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Biowave Corp.

Issue Date

Apr 27, 2017

Category

Device

Region

Northeast
Investigator(s): Michael G. Mayfield
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Oxford Performance Materials, Inc.

Issue Date

Apr 07, 2017

Category

Device

Region

Northeast
Investigator(s): Jeffrey J. Thibodeau
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Direx Systems Corp.

Issue Date

Apr 12, 2017

Category

Device

Region

Northeast
Investigator(s): John A. Sciacchitano
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Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Issue Date

Mar 23, 2017

Category

Drug

Region

Pacific
Investigator(s): Marcellinus Dordunoo, Linda F. Murphy, Taichun Qin
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SterRx

Issue Date

Mar 17, 2017

Category

Drug

Region

Northeast
Investigator(s): Rachael A. Moliver, Chad N. Thompson
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Mayo Clinic PET Radiochemistry Facility

Issue Date

May 11, 2017

Category

Drug

Region

Southwest
Investigator(s): Stephanie A. Slater
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Med-Tex, LLC dba Med Textile

Issue Date

Mar 03, 2017

Category

Device

Region

Central
Investigator(s): Joey C. West
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Coopervision, Inc.

Issue Date

Apr 13, 2017

Category

Device

Region

Northeast
Investigator(s): Elizabeth H. Davis, Matthew D. Schnittker
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SCM True Air Technologies, LLC

Issue Date

Mar 07, 2017

Category

Device

Region

Southeast
Investigator(s): Shannon A. Gregory
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Xinle Huabao Medical Products Co., Ltd.

Issue Date

Mar 02, 2017

Category

Device

Region

HQ
Investigator(s): Kelvin Cheung
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Southeastern Technology, Inc.

Issue Date

Apr 07, 2017

Category

Device

Region

Southeast
Investigator(s): Bonnie E. Conley
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Peter Schiff Enterprises

Issue Date

Apr 13, 2017

Category

Device

Region

Southeast
Investigator(s): Mary A. Millner, Andrew Saunders
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