The Knowledge Shelf

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

ORA and CDER agree to replace and/or withdraw CPGs in favor of using guidance or procedural documents, as appropriate per GGP regulations.

FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

CGMP/Finished Pharmaceuticals/Adulterated

CGMP/Finished Pharmaceuticals/Adulterated

FDA is posting 57 product-specific guidances to help industry generate evidence needed to support approval of generic drug applications

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

FDA issued a warning letter to Professional Compounding Centers of America Inc. (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs).

FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities.

FDA and Syapse presented Real-World Data at the American Association of Clinical Research (AACR) COVID-19 and Cancer meeting. Findings from study reveal higher risk of hospitalization and death among cancer patients with COVID-19.

FDA has issued draft guidance describing the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.