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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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Denali R&D Corp.

Issue Date

Jul 12, 2017

Category

Device

Region

Northeast
Investigator(s): James P. Finn
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Celltrion, Inc.

Issue Date

Jun 02, 2017

Category

Drug

Region

HQ
Investigator(s): Justin A. Boyd
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Buderer Drug Co., Inc.

Issue Date

Jul 24, 2017

Category

Drug

Region

Central
Investigator(s): Matthew Casale, Jazmine N. Still
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Biocon Ltd.

Issue Date

Jun 03, 2017

Category

Drug

Region

HQ
Investigator(s): Sandra A. Hughes, Eileen A. Lui
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Zhejiang Huahai Pharmaceutical Co., Ltd.

Issue Date

May 19, 2017

Category

Drug

Region

HQ
Investigator(s): Massoud Motamed
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Vital Laboratories Private Ltd.

Issue Date

Apr 03, 2017

Category

Drug

Region

HQ
Investigator(s): Christopher S. Keating
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Layerwise

Issue Date

Apr 06, 2017

Category

Device

Region

HQ
Investigator(s): Marc S. Neubauer
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Cenefom Corp.

Issue Date

Apr 07, 2017

Category

Device

Region

HQ
Investigator(s): Roy Baby
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Medicrea Technologies

Issue Date

Feb 16, 2017

Category

Device

Region

HQ
Investigator(s): Stephen D. Eich
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Motion Analysis Corp.

Issue Date

Jul 21, 2017

Category

Device

Region

Pacific
Investigator(s): Adam S. Freeman, Seema S. Singh
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Collagen Matrix, Inc.

Issue Date

Jul 18, 2017

Category

Device

Region

Central
Investigator(s): Ronald Ifraimov
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Dr. Reddy's Laboratories, Ltd.

Issue Date

Apr 28, 2017

Category

Drug

Region

HQ
Investigator(s): Cheryl Clausen, Angela E. Glenn
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