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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

Lloyd, Inc. of Iowa

Issued: 4/16/13
Region: Southwest
Category: Drug 483s
Inspector(s): Eric M. Mueller; Susanna E. Ford; Victoria A. Wagoner

Bell Pharmaceuticals, Inc.

Issued: 4/5/13
Region: Central
Category: Drug 483s
Inspector(s): April L. Young

LENSAR, Inc.

Issued: 3/21/13
Region: Southeast
Category: Device 483s
Inspector(s): Lisa A. Warner; Leo J. Lagrotte; Ashley A. Segura

Helena Laboratories, Inc.

Issued: 3/1/13
Region: Southwest
Category: Device 483s
Inspector(s): Ellen J. Tave

LifeSouth Community Blood Centers, Inc.

Issued: 1/31/13
Region: Southeast
Category: Drug 483s
Inspector(s): Danielle M. Maddox; Myla T. Collins

Terumo Cardiovascular Systems Corp.

Issued: 1/17/13
Region: Northeast
Category: Device 483s
Inspector(s): Camerson E. Moore

Rapid Trauma, LLC

Issued: 1/15/13
Region: Southwest
Category: Device 483s
Inspector(s): Roy Baby

Johns Hopkins University PET Center

Issued: 1/10/13
Region: Central
Category: Drug 483s
Inspector(s): Rachel C. Harrington

Beaumont Products, Inc.

Issued: 11/6/12
Region: Southeast
Category: Drug 483s
Inspector(s): Jawaid Hamid; David T. Glover

Safetec of America, Inc.

Issued: 8/21/12
Region: Northeast
Category: Drug 483s
Inspector(s): Karen L. Kosar; Marlene L. Davis

Drug Manufacturers

Lloyd, Inc. of Iowa

Issued: 4/16/13
Region: Southwest
Category: Drug 483s
Inspector(s): Eric M. Mueller; Susanna E. Ford; Victoria A. Wagoner

VVF Kansas Services, LLC

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

Bell Pharmaceuticals, Inc.

Issued: 4/5/13
Region: Central
Category: Drug 483s
Inspector(s): April L. Young

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

LifeSouth Community Blood Centers, Inc.

Issued: 1/31/13
Region: Southeast
Category: Drug 483s
Inspector(s): Danielle M. Maddox; Myla T. Collins

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

Device Manufacturers

Hitachi Medical Systems America, Inc.

Issued: 4/8/13
Region: Central
Category: Device 483s
Inspector(s): Benjamin J. Dastoli

Medtronic Neuromodulation

Issued: 4/3/13
Region: Central
Category: Device 483s
Inspector(s): Jessica L. Johnson; Susan M. Matthias

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

LENSAR, Inc.

Issued: 3/21/13
Region: Southeast
Category: Device 483s
Inspector(s): Lisa A. Warner; Leo J. Lagrotte; Ashley A. Segura

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