New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation

Unapproved New Drugs/Misbranded

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 1/14/2026
Short Title (70 char) US Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
FEI Number 3010680515
Firm Name US Specialty Formulations LLC
Record Type 483
State PA
Establishment Type Outsou

Costa Mesa, California — February 13, 2026 — Green Lumber Holding, LLC (“Green Lumber”) is issuing an updated consumer alert regarding counterfeit products falsely marketed as genuine Green Lumber products that may pose potential health risks.

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act