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FDA Form 483

FDA Form 483 Records

Browse through 17,444 fda form 483 records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.

FDA Form 483 Records

Showing 20 of 17,444 records

BSP Pharmaceuticals SpA

BSP Pharmaceuticals SpA
•
Dec 8, 2016
•ID: c8fc4c30...

Product: drugs

Office: FDA District Office — Silver Springs, Maryland

People: Francis A. Guidry (Investigator/Consumer Safety Officer), Xiaokuang Lai

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Catalent Pharma Solutions LLC

Catalent Pharma Solutions LLC
•
May 22, 2026
•ID: 5e16c0dd...

Product: drugs

Office: Atlanta District Office

People: Harrison E. Tandy, Ashley N. Samuel, Tanya R. Syffrard

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Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)

Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
•
Mar 19, 2024
•ID: c31ab762...

Product: drugs

Office: Office of Inspections and Investigations

People: Olumide A. Martins, Leiyun W. Boone (Lead Biologist), Orlando Martins

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Apotex Pharmachem India Pvt Ltd.

Apotex Pharmachem India Pvt Ltd.
•
Mar 14, 2025
•ID: 15522102...

Product: drugs

Office: Office of Inspections and Investigations

People: Yvins Dezan

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Bernd Richter GmbH

Bernd Richter GmbH
•
Feb 16, 2023
•ID: 50cef077...

Product: drugs

Office: Center for Devices and Radiological Health

People: Tiki Dixon

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3D Diagnostix Inc.

3D Diagnostix Inc.
•
Nov 21, 2025
•ID: f4ce0b97...

Product: device

Office: New England District Office

People: Sunita Pandey

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Amgen Singapore Manufacturing Pte Ltd

Amgen Singapore Manufacturing Pte Ltd
•
May 14, 2024
•ID: 8c61c98f...

Product: drugs

Office: Office of Inspections and Investigations

People: Thuy T. Nguyen ( Investigator, Consumer Safety Officer), Sudipan Karmakar, Liqun Zhao

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Aizant Drug Research Solutions Private Ltd.

Aizant Drug Research Solutions Private Ltd.
•
Jul 31, 2026
•ID: e9bbc5aa...

Product: drugs

Office: Office of Inspections and Investigations

People: Damaris Y. Hernandez

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APDM Pharmaceuticals Private Limited

APDM Pharmaceuticals Private Limited
•
Jun 12, 2026
•ID: 9cd867e8...

Product: drugs

Office: Office of Inspections and Investigations

People: Karishma G. Gopaul (Investigator)

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American Regent, Inc.

American Regent, Inc.
•
Apr 21, 2026
•ID: a1473890...

Product: drugs

Office: New York District Office

People: Vivin George, Tanya R. Syffrard, Divek R. Jumani (investigator)

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Molecular Imaging Program at Stanford

Molecular Imaging Program at Stanford
•
Apr 17, 2026
•ID: f12b5d0d...

Product: drugs

Office: San Francisco District Office

People: Sateesh Kum Sathigari, Matthew R. Clabeaux, Zachary L. Stamm (Pharmaceutical Program Expert)

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University of Texas Southwestern Medical Center, The

University of Texas Southwestern Medical Center, The
•
May 15, 2026
•ID: 735948db...

Product: drugs

Office: Division of Human and Animal Food Operations - West III

People: Shelby N. Turner

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Marcus Research Laboratory, Inc.

Marcus Research Laboratory, Inc.
•
May 6, 2026
•ID: 846aed50...

Product: drugs

Office: Division of Human and Animal Food Operations - West II

People: Matthew M. Schuckmann

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Air Products And Chemicals Inc

Air Products And Chemicals Inc
•
May 28, 2026
•ID: 0f9258de...

Product: drugs

Office: Division of Human and Animal Food Operations - West VI

People: Gloria E. Andia, Aranjeet Singh (FDA_PERSONNEL)

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Accupac, Llc

Accupac, Llc
•
Feb 13, 2026
•ID: 1ea3950d...

Product: other

Office: New Jersey District Office

People: Frank J. Marciniak

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Airgas USA LLC

Airgas USA LLC
•
Apr 23, 2026
•ID: 6e1e6d26...

Product: drugs

Office: Seattle District Office

People: Gloria E. Andia, Aranjeet Singh (FDA_PERSONNEL)

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Ashland Specialty Ingredients, G.P.

Ashland Specialty Ingredients, G.P.
•
Dec 22, 2025
•ID: 0e45a4cf...

Product: device

Office: New England District Office

People: Sara M. Onyango

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Always More Marketing Inc

Always More Marketing Inc
•
Oct 17, 2024
•ID: 73b221f1...

Product: device

Office: Los Angeles District Office

People: Kelvin Cheung

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Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.
•
Jun 3, 2026
•ID: b05c1eca...

Product: device

Office: New England District Office

People: Sunita Pandey, Thomas Siebertz

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Comfortland Medical, Inc.

Comfortland Medical, Inc.
•
Jun 12, 2026
•ID: 339b6877...

Product: device

Office: Atlanta District Office

People: Christopher B. May

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