www.buyprosoma.com

Warning LetterOpen

United StatesIssued Jun 10, 2025Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateJun 10, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: www.buyprosoma.com
Location: United States
FEI Number: N/A
Country: United States
Issue Date: June 10, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

www.buyprosoma.com was cited for unlawfully selling unapproved and misbranded opioids and benzodiazepines to U.S. consumers via the internet, in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA emphasized the severe public health risks associated with easy internet availability of these controlled substances, particularly given the ongoing opioid epidemic and the documented dangers of benzodiazepine nonmedical use, including polysubstance overdose deaths when combined with other drugs. Unapproved drugs lack the safety and effectiveness assurances required for FDA-approved medications, posing inherent risks to consumers who purchased from this website.