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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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HHS Systems, Inc.

Issue Date

Apr 25, 2019

Category

Device

Region

Northeast
Investigator(s): Andrew Garufi
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Aerolase Corp.

Issue Date

Aug 08, 2019

Category

Device

Region

Northeast
Investigator(s): Kwong Lee, Jacqueline S. Warner
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Suture Ease, Inc.

Issue Date

Aug 26, 2019

Category

Device

Region

Pacific
Investigator(s): Stanley B. Eugene
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Clinicon Corp.

Issue Date

Apr 04, 2019

Category

Device

Region

Pacific
Investigator(s): Daniel J. Lahar
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Biospace, Inc.

Issue Date

Apr 22, 2019

Category

Device

Region

Pacific
Investigator(s): Juanita Banuelos
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Kelyniam Global, Inc.

Issue Date

Aug 15, 2019

Category

Device

Region

Northeast
Investigator(s): Jeffrey J. Thibodeau
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Holistic Technologies, LLC

Issue Date

Aug 23, 2019

Category

Device

Region

Northeast
Investigator(s): James P. Finn
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Stephen B. Heitner

Issue Date

Aug 19, 2019

Category

Clinical

Region

Pacific
Investigator(s): Julian C. Hanson
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Michael C. Heinrich

Issue Date

Aug 16, 2019

Category

Clinical

Region

Pacific
Investigator(s): Mark W. Babbitt
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Sandoz Private Ltd.

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Yasamin Ameri
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Patheon, Inc.

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Latorie S. Jones
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Specialty Electronic Materials Switzerland GmbH

Issue Date

Apr 12, 2019

Category

Drug

Region

HQ
Investigator(s): Tamil Arasu
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