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FDAnews Form 483s

Now you can purchase original-source 483s containing the actual observations made by FDA inspectors. Use them to avoid mistakes made by your competitors and other companies similar to yours. It's a quick, convenient and affordable way to learn all the details of each 483, with only proprietary business information redacted by the FDA. Order your copies today.

Just Added

Inovise Medical, Inc.

Issued: 3/21/13
Region: Pacific
Category: Device 483s
Inspector(s): James D. Hildreth

E. Benson Hood Laboratories, Inc.

Issued: 12/21/12
Region: Northeast
Category: Device 483s
Inspector(s): Elizabeth B. Griffin

Acra Cut, Inc.

Issued: 12/14/12
Region: Northeast
Category: Device 483s
Inspector(s): Jonathan B. Lewis

Arteriocyte Medical Systems, Inc.

Issued: 12/11/12
Region: Northeast
Category: Device 483s
Inspector(s): Camerson E. Moore

Limerick, Inc.

Issued: 12/7/12
Region: Pacific
Category: Device 483s
Inspector(s): Kelvin Cheung

OHM Pharma, Inc.

Issued: 11/30/12
Region: Southwest
Category: Drug 483s
Inspector(s): Anh Lac

Cardinal Health 414, Inc.

Issued: 11/30/12
Region: Southwest
Category: Drug 483s
Inspector(s): Stephen D. Brown

RX Air Industries, LLC

Issued: 11/15/12
Region: Southwest
Category: Device 483s
Inspector(s): Roy Baby; Daniel S. Fam

American Aesthetics Medical Supply, Inc.

Issued: 11/13/12
Region: Southwest
Category: Drug 483s
Inspector(s): H.L. Jamillah Selby; Lauren E. Skokan

Kremers Urban Pharmaceuticals, Inc.

Issued: 11/2/12
Region: Central
Category: Drug 483s
Inspector(s): Jeffrey D. Meng; Larry K. Austin

Drug Manufacturers

Novartis Consumer Health

Issued: 2/14/13
Region: Southwest
Category: Drug 483s
Inspector(s): Eric M. Mueller; Susanna E. Ford; Joseph R. Lambert

Shippert Medical Technologies

Issued: 1/28/13
Region: Southwest
Category: Drug 483s
Inspector(s): Christine I. Shaw; Ashleigh P. Barkans

Reliable Biopharmaceutical Corp.

Issued: 1/25/13
Region: Southwest
Category: Drug 483s
Inspector(s): Michele L. Obert

Piramal Critical Care, Inc.

Issued: 1/24/13
Region: Central
Category: Drug 483s
Inspector(s): James M. Mason

Gadal Laboratories, Inc.

Issued: 1/23/13
Region: Southeast
Category: Drug 483s
Inspector(s): Ileana Barreto-Pettit

Visionary Optics, LLC

Issued: 1/22/13
Region: Central
Category: Drug 483s
Inspector(s): Cynthia A. Harris

Dercher Enterprises, Inc., dba Gordon Laboratories

Issued: 1/18/13
Region: Central
Category: Drug 483s
Inspector(s): Anita R. Michael

Mobius Therapeutics, LLC

Issued: 1/17/13
Region: Southwest
Category: Drug 483s
Inspector(s): Eric M. Padgett

Lincare, Inc.

Issued: 1/16/13
Region: Southwest
Category: Drug 483s
Inspector(s): Heath W. Cartwright

Advanced Pharmaceutical, Inc.

Issued: 1/11/13
Region: Northeast
Category: Drug 483s
Inspector(s): Alice S. Tsao

Device Manufacturers

Inovise Medical, Inc.

Issued: 3/21/13
Region: Pacific
Category: Device 483s
Inspector(s): James D. Hildreth

The Lifestyle GP Company, LLC

Issued: 1/29/13
Region: Southeast
Category: Device 483s
Inspector(s): Melanie G. Warzala

Unimed Surgical Products, Inc.

Issued: 1/28/13
Region: Southeast
Category: Device 483s
Inspector(s): Leo J. Lagrotte

SCM True Air Technologies, LLC

Issued: 1/24/13
Region: Central
Category: Device 483s

Dyna-Tek Industries

Issued: 1/24/13
Region: Southwest
Category: Device 483s
Inspector(s): James D. Planchon; Jonathan R. Campos

Intelligent Hearing Systems Corp.

Issued: 1/22/13
Region: Southeast
Category: Device 483s
Inspector(s): Karen M. Rodriguez; Sean T. Creighton

nContact Surgical, Inc.

Issued: 1/18/13
Region: Southeast
Category: Device 483s
Inspector(s): Miaja Umaedi

Electro Kinetic Technologies, LLC

Issued: 1/17/13
Region: Central
Category: Device 483s
Inspector(s): Melissa J. Holz

Bioresource Technology, Inc.

Issued: 1/16/13
Region: Southeast
Category: Device 483s
Inspector(s): Ashley A. Segura

Captiva Spine, Inc.

Issued: 1/16/13
Region: Southeast
Category: Device 483s
Inspector(s): Richard K. Vogel