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FDA Office
•USA

Office of Pharmaceutical Quality Operations

View detailed information about Office of Pharmaceutical Quality Operations, including compliance records, people, and regulatory data.

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Office Profile

Comprehensive profile of Office of Pharmaceutical Quality Operations, including its role, location, and regulatory activities.

People (8)
Thomas R. Berry
FDA_ASSOCIATED_PERSON
John W. Diehl
FDA_ASSOCIATED_PERSON
Darren S. Brown
FDA_ASSOCIATED_PERSON
Liatte Krueger
FDA_ASSOCIATED_PERSON
Juan Jiménez
FDA_ASSOCIATED_PERSON
Alonza E. Cruse
FDA_ASSOCIATED_PERSON
Art O. Czabaniuk
FDA_ASSOCIATED_PERSON
Rebecca Asente
FDA_ASSOCIATED_PERSON
Records (20)
483 - Shandong Anhong Pharmaceutical Co., Ltd.

drugs • June 26, 2026

483
483 - Intas Pharmaceuticals Ltd.

drugs • September 17, 2025

483
483 - Biocon Biologics Limited

biologics • September 3, 2025

483
483 - Ajinomoto Co. Inc. Kyushu Plant

drugs • July 18, 2025

483
EIR - Baxter Oncology GmbH

drugs • August 27, 2024

EIR
483 - Cipla, Ltd.

May 8, 2024

483
483 - Zydus Lifesciences Limited

Biologics • March 27, 2024

483
483 - Eugia SEZ Private Limited

February 29, 2024

483
483 - SUMAR BIOTECH LLP

drugs • January 12, 2024

483
483 - Nanchang Anobri Pharmaceutical CO., LTD

drugs • November 13, 2023

483
EIR - Ote Pharma Sol B.V.

Drugs • September 15, 2023

EIR
483 - APARNA ORGANICS LIMITED

drugs • September 11, 2023

483
WARNING_LETTER - National Chemical Laboratories

Drugs • May 26, 2023

WARNING_LETTER
483 - Keshava Organics Private Ltd.

drugs • January 13, 2023

483
483 - Intas Pharmaceuticals Limited

December 2, 2022

483
483 - Torrent Pharmaceuticals Limited

September 28, 2022

483
EIR - KBI Biopharma, Inc.

Biologics • January 13, 2022

EIR
WARNING_LETTER - Ultra Seal Corporation

Drugs • September 14, 2021

WARNING_LETTER
EIR - Yung Shin Pharmaceutical Industry Co., Ltd.

drugs • June 21, 2021

EIR
483 - Kreative Organics Private Limited

drugs • February 7, 2020

483

Showing 1 to 20 of 20 records

Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Office of Pharmaceutical Quality Operations

Abbreviation

OPQO

Country

USA

Postal Code

20857

State/Province

Maryland

City

Rockville

Address

12420 Parklawn Drive

Office Website

Visit Website

ID: 6b0153a9-c1d1-46a5-8b10-836d2ae44ffe

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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