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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.

Placeholderbook

Tram K. Tran-Johnson

Issue Date

Feb 01, 2019

Category

Clinical

Region

Pacific
Investigator(s): Marilyn S. Babu, Ni A. Khin, Diane C. Van Leeuwen
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Placeholderbook

Stuart L. Silverman

Issue Date

Feb 01, 2019

Category

Clinical

Region

Pacific
Investigator(s): Sunitha K. Rajaram
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Placeholderbook

Kyowa Hakka Kirin Co.

Issue Date

Dec 11, 2018

Category

Drug

Region

HQ
Investigator(s): Dennis Cantellops
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Placeholderbook

Ingenus Pharmaceuticals GmbH

Issue Date

Dec 11, 2018

Category

Drug

Region

HQ
Investigator(s): Yasamin Ameri
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Placeholderbook

Mylan Laboratories Ltd.

Issue Date

Dec 10, 2018

Category

Drug

Region

HQ
Investigator(s): Darren S. Brown, Nayan J. Patel
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Placeholderbook

Swabplus, L.P.

Issue Date

Apr 11, 2019

Category

Drug

Region

Pacific
Investigator(s): Diane R. Weidley, Marcus F. Yambot
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Placeholderbook

Lifetech Resources, LLC

Issue Date

Apr 05, 2019

Category

Drug

Region

Pacific
Investigator(s): Alan L. Truong
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Placeholderbook

Kohana Pharmacy and Center for Regenerative Medicine, Inc.

Issue Date

Apr 17, 2019

Category

Drug

Region

Pacific
Investigator(s): Uttaniti Limchumroon
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Placeholderbook

Invitrx Therapeutics, Inc.

Issue Date

Apr 03, 2019

Category

Drug

Region

Pacific
Investigator(s): Scott T. Ballard, Laurissa S. Flowers
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Placeholderbook

Herbal Doctor Remedies

Issue Date

Apr 19, 2019

Category

Drug

Region

Pacific
Investigator(s): Anita Narula, Diane R. Weidley
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Placeholderbook

Diamond Wipes International, Inc.

Issue Date

Apr 19, 2019

Category

Drug

Region

Pacific
Investigator(s): Nicholas L. Hunt, Santiago Gallardo Johnson
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Placeholderbook

Alden Medical, LLC

Issue Date

Apr 23, 2019

Category

Drug

Region

Northeast
Investigator(s): Robert J. Martin, Jonah S. Ufferfilge
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