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Surveillance of Anabolic Agent Residues in US Meat Supply by Liquid Chromatography With High‐Resolution Tandem Mass Spectrometry

Edible meat samples obtained from across the United States were found to be well below the established Codex MRLs for…

Generic Drug Research-Related Guidances & Reports

The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for…

FY 2024 GDUFA Science and Research Report

The FY 2024 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to…

Yahon Enterprise Co., Ltd. – 675592 – 06/05/2024

CGMP/Finished Pharmaceuticals/Adulterated

Genuine Virgin Aloe Corp dba Triderma – 679744 – 07/01/2024

CGMP/Finished Pharmaceuticals/Adulterated

V10Suppliers.com – 685496 – 07/22/2024

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Brassica Pharma Pvt. Ltd. – 679005 – 07/11/2024

CGMP/Finished Pharmaceuticals/Adulterated

Advisory Letters

Advisory Letters

Empower Clinic Services, LLC dba Empower Pharmacy – 700964 – 04/02/2025

Compounding Pharmacy/Adulterated Drug Products

Bailey’s Wellness, LLC dba Bailey’s CBD – 701066 – 04/07/2025

Unapproved New Animal Drug Products