FDA Office

USA

Division of Pharmaceutical Quality Operations IV

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

Office Profile

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

People (4)

Katherine E. Jacobitz

FDA_ASSOCIATED_PERSON

Steven E. Porter

FDA_ASSOCIATED_PERSON

Lance M. De Souza

FDA_ASSOCIATED_PERSON

Andrew K. Haack

FDA_ASSOCIATED_PERSON

Records (20)

483 - Grifols Biologicals LLC

biologics • September 12, 2019

483

483 - Baxalta US Inc.

biologics • January 17, 2020

483

483 - Acadia Pharmaceuticals Inc.

drugs • January 27, 2021

483

483 - Grifols Biologicals LLC

biologics • September 12, 2019

483

483 - Advanced Bionics Corp.

device • December 21, 2001

483

483 - Cooler Heads Care, Inc.

device • August 6, 2026

483

483 - Medical Packaging Corporation

device • July 23, 2026

483

483 - GUIDEMIA TECHNOLOGIES LLC

device • July 6, 2026

483

483 - Inhibrx Biosciences Inc.

drugs • July 2, 2026

483

483 - Eurofins Advantar Laboratories, Inc

drugs • June 30, 2026

483

483 - Advanced Cosmetic Research Laboratories, Inc.

drugs • June 26, 2026

483

483 - MedAlliance, LLC

device • June 18, 2026

483

483 - Bioplate Inc

device • June 1, 2026

483

483 - Cosmoceutical Research Center, Inc.

drugs • May 29, 2026

483

483 - Pacific Science LLC

drugs • May 28, 2026

483

483 - PETNET SOLUTIONS, INC.

drugs • May 22, 2026

483

483 - PLZ Corp

drugs • May 21, 2026

483

483 - Biosense Webster, Inc.

device • May 20, 2026

483

483 - Biofilm, Inc.

device • May 19, 2026

483

483 - LGM Pharma Solutions, LLC

drugs • May 18, 2026

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

Division of Pharmaceutical Quality Operations IV

Abbreviation

OPQO4

Country

USA

Postal Code

92612

State/Province

California

City

Irvine

Address

19701 Fairchild

Office Website

Visit Website

ID: a2d2ff91-dc0f-433e-b91f-ca90ff8998b6

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