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Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

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Biotika A.S.

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Tiara N. Brown-Crosen
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Glaxo Wellcome Manufacturing Pte Ltd.

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Jose E. Melendez
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Mallinckrodt Medical B.V.

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Yvins Dezan
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Cosmetica Laboratories, Inc.

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Mindy M. Chou
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Pekana Naturheilmittel GmbH

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Stephanie A. Slater
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Jubilant HollisterStier General Partnership

Issue Date

Jun 01, 2018

Category

Drug

Region

HQ
Investigator(s): Brett R. Havranek
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Streck

Issue Date

Sep 20, 2018

Category

Device

Region

Southwest
Investigator(s): Juliane C. Lessard, Eric M. Padgett
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Zevex Inc.

Issue Date

Sep 17, 2018

Category

Device

Region

Southwest
Investigator(s): James R. Montero, Matthew M. Vernon
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Thatcher Co.

Issue Date

Sep 18, 2018

Category

Device

Region

Southwest
Investigator(s): Christopher M. Jenner
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SPS National Labs-Tempe

Issue Date

Sep 19, 2018

Category

Device

Region

Pacific
Investigator(s): Charles L. Larson
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Winfield Laboratories, Inc.

Issue Date

Sep 25, 2018

Category

Device

Region

Southwest
Investigator(s): Jude C. Dike
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Microlight Corp. of America

Issue Date

Sep 06, 2018

Category

Device

Region

Southwest
Investigator(s): Jocelyn C. Turner
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