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FDAnews Form 483s

Integrated Medical Devices, Inc.

Issued: 9/21/09
Category: Device 483s
Inspector(s): Nicholas C. Mendiola

Galix Biomedical Instrumentation, Inc.

Issued: 9/21/09
Category: Device 483s
Inspector(s): Althea A. Williams

CareFusion 203, Inc.

Issued: 9/18/09
Category: Device 483s
Inspector(s): Susan M. Atcher

Ocu-Ease Optical Products, Inc.

Issued: 9/16/09
Category: Device 483s
Inspector(s): Catherine J. Laufmann

New Leaf Medical, Inc.

Issued: 9/16/09
Category: Device 483s
Inspector(s): Laureen M. Geniusz

Chinook Medical Gear, Inc.

Issued: 9/16/09
Category: Device 483s
Inspector(s): Thai Duong

Siemens Water Technologies Corp.

Issued: 9/15/09
Category: Device 483s
Inspector(s): Gary L. Zaharek

Durden Enterprises, Inc.

Issued: 9/15/09
Category: Device 483s
Inspector(s): Babatunde D. Babalola, Dellarese L. Herbert

Gibson Laboratories, Inc.

Issued: 9/14/09
Category: Device 483s
Inspector(s): Pamela A. Kuist

American Contract Systems, Inc.

Issued: 9/14/09
Category: Device 483s
Inspector(s): Aaron L. Dunbar, Michelle J. Glambin

Rockwell Medical Technologies, Inc.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Ryan J. Benedict

PrimaPharm, Inc.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Jennifer M. Gogley, Caryn M. McNab, Joey V. Quitanis, Nelly N. Tran

NexAir, LLC

Issued: 9/11/09
Category: Device 483s
Inspector(s): Karl O. Hezel

Multi-Med, Inc.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Darin S. Wiegers

Byron Medical, Inc.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Charles L. Larson

Berkeley Medevices, Inc.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Catherine J. Laufmann

Amgen Manufacturing, Ltd.

Issued: 9/11/09
Category: Device 483s
Inspector(s): Jose E. Melendez, Donald C. Obenhuber

Xintec Corp.

Issued: 9/10/09
Category: Device 483s
Inspector(s): Catherine J. Laufmann

Orthomerica Products, Inc.

Issued: 9/10/09
Category: Device 483s
Inspector(s): Andrea H. Norwood, Deborah A. Racioppi

Northeast Resins & Silicones, LLC

Issued: 9/10/09
Category: Device 483s
Inspector(s): Kimberly Levandowski-Walker

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