FDA Office

United States

Foreign - CDER (Non-Bioresearch Monitoring)

View detailed information about Foreign - CDER (Non-Bioresearch Monitoring), including compliance records, people, and regulatory data.

Office Profile

Comprehensive profile of Foreign - CDER (Non-Bioresearch Monitoring), including its role, location, and regulatory activities.

Records (20)

483 - Nippon Fine Chemical Co., Ltd.

drugs • November 14, 2025

483

483 - MSD International GmbH (Singapore Branch)

drugs • January 23, 2026

483

483 - ABRYL LABORATORIES PRIVATE LIMITED

drugs • September 26, 2025

483

483 - Cohance Lifesciences Limited

Drugs • August 12, 2025

483

483 - Kemwell Biopharma Private Ltd

drugs • May 20, 2025

483

483 - Zydus Lifesciences Limited

drugs • April 25, 2025

483

483 - SRI Krishna Pharmaceuticals Ltd - Unit I

drugs • April 18, 2025

483

483 - Piramal Pharma Limited

drugs • February 13, 2025

483

483 - Daewoo Pharmaceutical Co., Ltd.

Drugs • January 15, 2025

483

483 - Janssen Vaccines Corporation

Devices • November 19, 2024

483

483 - Biocon Sdn. Bhd. (Company No. 201101002193)

Drugs • September 27, 2024

483

483 - ABRYL LABORATORIES PRIVATE LIMITED

drugs • August 20, 2024

483

483 - Neurotech Pharmaceuticals, Inc.

biologics • July 26, 2024

483

483 - Joinn Laboratories Co. Ltd.

biologics • May 21, 2024

483

483 - Unexo Life Sciences Private Limited

drugs • May 14, 2024

483

483 - ABRYL LABORATORIES PRIVATE LIMITED

drugs • November 20, 2023

483

483 - Hamari PFST, Ltd.

drugs • November 10, 2023

483

483 - Panacea Biotec Pharma Limited

Drugs • October 12, 2023

483

483 - Minteq UK Limited

August 29, 2023

483

483 - Organo Sintesis, S.A. De C.V.

drugs • July 28, 2023

483

Showing 1 to 20 of 20 records

Related Offices (5)

Division of Blood Components and Devices

CBER-DBCD

Foreign - CBER (Bioresearch Monitoring)

FR B BMO

Foreign - CBER (Non-Bioresearch Monitoring)

FR B N-BMO

Foreign - CDER (Bioresearch Monitoring)

FR D BMO

Foreign - CDRH (Bioresearch Monitoring)

FR Z BMO

Office Information

Name

Foreign - CDER (Non-Bioresearch Monitoring)

Abbreviation

FR D N-BMO

Country

United States

Postal Code

20857

State/Province

Maryland

City

Rockville

Address

Parklawn Drive, 12420 Parklawn Drive

ID: 279f5818-f62e-40c9-951c-cfbc7f929fa1

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