US FDA

PDUFA Performance Reports

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
FEI Number 3010589333
Firm Name Right Value Drug Stores, LLC
Record Type 483
State TX
Establishment Type Outsourci

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/23/2025
Short Title (70 char) Stokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 05/23/2025
FEI Number 3002815949
Firm Name Stokes Healthcare Inc. dba Epicur Pharma
Record Type 483
State N

Neuhaus Chocolates NV of Vlezenbeek, BELGIUM has initiated a voluntary recall for : Belgian Chocolate Moments Smurfs ‘Popping Milk Chocolates with Cookies, because it contains undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening alle

DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.

Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing Facilit

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/18/2025
Short Title (70 char) QuVa Pharma, Inc. Sugar Land, TX. Untitled Letter issued 06/18/2025
FEI Number 3012053582
Firm Name QuVa Pharma, Inc
Record Type 483
State TX
Establishment Type Outsourcing Facil

The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.

Learn how to spot health fraud and avoid it.

Advisory letter issued to Ananeoo Wellness LLC for the marketing of Ananeoo Cellular Nutrition & Detoxification on ananeoowellness.com