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Division of Pharmaceutical Quality Operations I

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

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Office Profile

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

People (4)
Nerizza Guerin
FDA_ASSOCIATED_PERSON
Stephanie Durso
FDA_ASSOCIATED_PERSON
Liatte Closs
FDA_ASSOCIATED_PERSON
Lisa M. Harlan
FDA_ASSOCIATED_PERSON
Records (20)
483 - Haisco-USA Pharmaceuticals, Inc.

drugs • October 9, 2025

483
483 - Aucta Pharmaceuticals, Inc.

drugs • October 3, 2025

483
EIR - Advanced Accelerator Applications USA, Inc.

drugs • June 27, 2024

EIR
WARNING_LETTER - Diamond Chemical Co., Inc.

Drugs • May 16, 2024

WARNING_LETTER
WARNING_LETTER - Clean Solutions LLC

Drugs • May 10, 2024

WARNING_LETTER
WARNING_LETTER - LS Promotions Inc.

Drugs • May 2, 2024

WARNING_LETTER
WARNING_LETTER_RESPONSE - Barclay, Luke, & Pillai Specialty Pharmacy, PLLC

Drugs • March 15, 2024

WARNING_LETTER_RESPONSE
WARNING_LETTER - Kaylaan LLC

Drugs • March 1, 2024

WARNING_LETTER
WARNING_LETTER - Aerosol and Liquid Packaging, Inc.

Drugs • December 18, 2023

WARNING_LETTER
UNTITLED_LETTER - Wedgewood Connect, LLC

Drugs • November 17, 2023

UNTITLED_LETTER
UNTITLED_LETTER - Wedgewood Connect, LLC

Drugs • November 9, 2023

UNTITLED_LETTER
WARNING_LETTER - Stokes Healthcare Inc. dba Epicur Pharma

Drugs • October 25, 2023

WARNING_LETTER
UNTITLED_LETTER - Precision Equine, LLC

Drugs • September 22, 2023

UNTITLED_LETTER
UNTITLED_LETTER - Precision Equine, LLC

Drugs • September 12, 2023

UNTITLED_LETTER
UNTITLED_LETTER - Wickliffe Pharmaceutical Inc

Drugs • September 7, 2023

UNTITLED_LETTER
WARNING_LETTER - Inopak, Ltd.

Drugs • August 3, 2023

WARNING_LETTER
WARNING_LETTER - Central Admixture Pharmacy Services, Inc.

Drugs • March 30, 2023

WARNING_LETTER
WARNING_LETTER - Delsam Pharma LLC

Drugs • March 24, 2023

WARNING_LETTER
WARNING_LETTER - EzriCare LLC

Drugs • March 21, 2023

WARNING_LETTER
WARNING_LETTER - Safecor Health, LLC

Drugs • March 16, 2023

WARNING_LETTER

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 I

Abbreviation

OPQO1

Country

USA

Postal Code

7054

State/Province

New Jersey

City

Parsippany

Address

10 Waterview Boulevard, 3rd Floor

Office Website

Visit Website

ID: 6ded4818-ee3a-46a1-84c1-36de58502b02

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