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FDA Form 483

FDA Form 483 Records

Browse through 16,086 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 16,086 records

Par Formulations Private Limited

Par Formulations Private Limited
•
Jun 10, 2026
•ID: fef7f7a7...

Product: drugs

Office: Office of Inspections and Investigations

People: Yvins Dezan

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Olympus Medical Systems Corporation

Olympus Medical Systems Corporation
•
Nov 21, 2025
•ID: 0eecfb1a...

Product: device

Office: Office of Inspections and Investigations

People: Rebecca E. Dorsey, Janet Pulver (Investigator)

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Zydus Pharmaceuticals Limited

Zydus Pharmaceuticals Limited
•
Sep 28, 2026
•ID: 8e9ca000...

Product: drugs

Office: Office of Inspections and Investigations

People: Lillian S. Wu, Sara H. Gabel

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SINO MEDICAL SCIENCES TECHNOLOGY INC

SINO MEDICAL SCIENCES TECHNOLOGY INC
•
Aug 24, 2023
•ID: 74b56af8...

Product: device

Office: Office of Medical Device and Radiological Health Operations

People: Joshua J. Silvestri

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Actimus Biosciences Private Limited

Actimus Biosciences Private Limited
•
Jan 25, 2024
•ID: c7cdc117...

Product: drugs

Office: Division of Advertising & Promotion

People: Courtney N. Long (investigator), Alanna L. Mussawwir Bias

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Advity Research Private, Limited

Advity Research Private, Limited
•
Mar 15, 2024
•ID: ebabd9ed...

Product: drugs

Office: FDA District Office — Silver Springs, Maryland

People: Dawn C. Olenjack

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AGC WAKASA CHEMICALS CO., LTD.

AGC WAKASA CHEMICALS CO., LTD.
•
Aug 21, 2026
•ID: 96649359...

Product: drugs

Office: Office of Inspections and Investigations

People: Dorothy P. Kramer

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Apnar Pharma Private Limited

Apnar Pharma Private Limited
•
Sep 11, 2026
•ID: 798177ba...

Product: drugs

Office: Office of Inspections and Investigations

People: Tanya R. Syffrard

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Noven Pharmaceuticals Inc

Noven Pharmaceuticals Inc
•
Aug 24, 2026
•ID: 39396e04...

Product: drugs

Office: Florida District Office

People: Michael Z. Weigman

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XF Enterprises, Inc

XF Enterprises, Inc
•
Jul 2, 2025
•ID: 5d05b0f1...

Product: veterinary

Office: Philadelphia District Office

People: Kyle D. Covill (Investigator)

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AptaPharma Inc.

AptaPharma Inc.
•
Aug 14, 2026
•ID: d630bef8...

Product: drugs

Office: New Jersey District Office

People: Michael O. Idowu (issuing_officer)

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BioMarin Pharmaceutical, Inc.

BioMarin Pharmaceutical, Inc.
•
Jun 9, 2026
•ID: 3d9f6c03...

Product: biologics

Office: San Francisco District Office

People: Joey V. Quitania (Public Affairs Specialist), Matthew R. Clabeaux, Ana-Maria A. Plapcianu ( analyst /Microbiologist )

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Cosmoceutical Research Center, Inc.

Cosmoceutical Research Center, Inc.
•
May 29, 2026
•ID: 0f85a49b...

Product: drugs

Office: Division of Pharmaceutical Quality Operations IV

People: Michael Araneta (issuing_officer), Alexandra A. Cole, Joshua S. Lee

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Alexander Glaros, M.D.

Alexander Glaros, M.D.
•
Jul 17, 2026
•ID: 6afd8208...

Product: drugs

Office: Detroit District Office

People: Jason Woodward, Dina A. Tallman (investigator)

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Capricor, Inc.

Capricor, Inc.
•
Jul 20, 2026
•ID: 7309898f...

Product: other

Office: Los Angeles District Office

People: Samson O. Oluseye

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AVEVA Drug Delivery Systems, Inc.

AVEVA Drug Delivery Systems, Inc.
•
Aug 14, 2026
•ID: 0db5a545...

Product: drugs

Office: Florida District Office

People: Santos E. Camara, Ashley N. Samuel

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Bryant Ranch Prepack, Inc.

Bryant Ranch Prepack, Inc.
•
Jul 16, 2026
•ID: e6988287...

Product: drugs

Office: Los Angeles District Office

People: Navneet Kaur, Pearl C. Ozuruigbo

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Enterix, Inc.

Enterix, Inc.
•
Aug 10, 2026
•ID: 87ea6ba4...

Product: device

Office: Center for Devices and Radiological Health

People: Frank J. Marciniak

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Dimensional Merchandising Inc DBA: DMI Personal Care

Dimensional Merchandising Inc DBA: DMI Personal Care
•
Jul 21, 2026
•ID: a02fc66d...

Product: drugs

Office: New Jersey District Office

People: Emmanuel T. Donyina

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Northern Biomedical Research, Inc.

Northern Biomedical Research, Inc.
•
Jul 31, 2026
•ID: 9932e84b...

Product: other

Office: Detroit District Office

People: Corrine M. Carter (investigator), Chelsea W. Lamm (investigator), Victoria R. Flournoy

View Details
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