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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

MicroSurgical Technology, Inc.

Issued: 3/20/13
Region: Pacific
Category: Device 483s
Inspector(s): Paul M. Kawamoto

International Rehabilitative Sciences, Inc. dba RS Medical

Issued: 3/15/13
Region: Pacific
Category: Drug 483s
Inspector(s): Stanley B. Eugene

Continental Manufacturing Chemist, Inc.

Issued: 3/15/13
Region: Southwest
Category: Drug 483s
Inspector(s): Brittany D. Terhar; Candace S. Tucker

Mega Sun, Inc.

Issued: 3/6/13
Region: Southwest
Category: Device 483s
Inspector(s): Eric M. Padgett

The Flexite Company

Issued: 1/9/13
Region: Northeast
Category: Device 483s
Inspector(s): Kwong Lee

Del Medical, Inc.

Issued: 12/17/12
Region: Central
Category: Device 483s
Inspector(s): Joseph A. Morkunas

American Pharmaceuticals & Cosmetics, Inc.

Issued: 12/12/12
Region: Southwest
Category: Drug 483s
Inspector(s): Stephen D. Brown; Jodi M. Gatica; Lourdes R. Genera

Cyberonics, Inc.

Issued: 12/7/12
Region: Southwest
Category: Device 483s
Inspector(s): Kelly D. Sheppard; Sean T. Creighton

Dermazone Solutions, Inc.

Issued: 11/1/12
Region: Southeast
Category: Drug 483s
Inspector(s): Nicole E. Knowlton; Mizanne E. Lewis

Sigma-Tau Pharmasource, Inc.

Issued: 5/11/12
Region: Central
Category: Drug 483s
Inspector(s): Robert M. Barbosa; Larry K. Austin

Drug Manufacturers

International Rehabilitative Sciences, Inc. dba RS Medical

Issued: 3/15/13
Region: Pacific
Category: Drug 483s
Inspector(s): Stanley B. Eugene

Continental Manufacturing Chemist, Inc.

Issued: 3/15/13
Region: Southwest
Category: Drug 483s
Inspector(s): Brittany D. Terhar; Candace S. Tucker

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

Mid-Continent Packaging, Inc.

Issued: 1/24/13
Region: Southwest
Category: Drug 483s
Inspector(s): Margaret M. Annes

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

Device Manufacturers

Inovise Medical, Inc.

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

MicroSurgical Technology, Inc.

Issued: 3/20/13
Region: Pacific
Category: Device 483s
Inspector(s): Paul M. Kawamoto

Mega Sun, Inc.

Issued: 3/6/13
Region: Southwest
Category: Device 483s
Inspector(s): Eric M. Padgett

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