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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

VVF Kansas Services, LLC

Issued: 4/11/13
Region: Southwest
Category: Drug 483s
Inspector(s): Michele L. Obert; Jessica E. Hensley; Matthew R. Sleeter

Cedarburg Pharmaceuticals, Inc.

Issued: 4/4/13
Region: Central
Category: Drug 483s
Inspector(s): Joel D. Hustedt

Remote Technologies, Inc.

Issued: 3/13/13
Region: Northeast
Category: Device 483s
Inspector(s): Stephen C. Smith

Digicare Biomedical Technology, Inc.

Issued: 3/12/13
Region: Southeast
Category: Device 483s
Inspector(s): Lisa A. Warner

Omega Packaging Corp.

Issued: 1/28/13
Region: Central
Category: Drug 483s
Inspector(s): Helen Verdel

BFS Pharma, Inc.

Issued: 1/17/13
Region: Northeast
Category: Drug 483s
Inspector(s): Stacey S. Degarmo; Rory Geyer

PETNET Solutions, Inc.

Issued: 1/17/13
Region: Southeast
Category: Drug 483s
Inspector(s): Marvin D. Jones; Claire M. Minden

Bio-Concept Laboratories, Inc.

Issued: 1/10/13
Region: Northeast
Category: Drug 483s
Inspector(s): Edmund F. Mrak, Jr.

Hamilton Thorne, Inc.

Issued: 1/10/13
Region: Northeast
Category: Device 483s
Inspector(s): John A. Sciacchitano

Fresenius Medical Care North America

Issued: 1/7/13
Region: Southwest
Category: Device 483s
Inspector(s): Lauren E. Skokan; Roy Baby

Drug Manufacturers

VVF Kansas Services, LLC

Issued: 4/11/13
Region: Southwest
Category: Drug 483s
Inspector(s): Michele L. Obert; Jessica E. Hensley; Matthew R. Sleeter

Cedarburg Pharmaceuticals, Inc.

Issued: 4/4/13
Region: Central
Category: Drug 483s
Inspector(s): Joel D. Hustedt

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

AMRI Rensselaer, Inc.

Issued: 1/30/13
Region: Northeast
Category: Drug 483s
Inspector(s): W. Martin Rennells; Dana A Razzano

Omega Packaging Corp.

Issued: 1/28/13
Region: Central
Category: Drug 483s
Inspector(s): Helen Verdel

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

Device Manufacturers

Agfa Healthcare Corp.

Issued: 3/29/13
Region: Central
Category: Device 483s
Inspector(s): Doreen P. Canetti

UltraRad Corp.

Issued: 3/26/13
Region: Central
Category: Device 483s
Inspector(s): Meredith L. Sheridan

Osseon Therapeutics, Inc.

Issued: 3/22/13
Region: Pacific
Category: Device 483s
Inspector(s): Lydia S. Chan

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

SpenTech, Inc. dba Spencer Technologies

Issued: 3/19/13
Region: Pacific
Category: Device 483s
Inspector(s): Sharon I. Gundersen

SentreHeart, Inc.

Issued: 3/19/13
Region: Pacific
Category: Device 483s
Inspector(s): Jude C. Dike

Mirador Biomedical, Inc.

Issued: 3/19/13
Region: Pacific
Category: Device 483s
Inspector(s): Stephen R. Souza

Remote Technologies, Inc.

Issued: 3/13/13
Region: Northeast
Category: Device 483s
Inspector(s): Stephen C. Smith

Digicare Biomedical Technology, Inc.

Issued: 3/12/13
Region: Southeast
Category: Device 483s
Inspector(s): Lisa A. Warner