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WARNING LETTER
•www.usaquickmeds.com•August 19, 2025

www.usaquickmeds.com – FDA Warning Letter, Aug 19, 2025

Record Details

The FDA issued a warning letter to USA Quick Meds on August 1, 2025, following a review of their website, www.usaquickmeds.com. The inspection revealed the unlawful sale of unapproved and misbranded drugs, specifically opioids and benzodiazepines, to U.S. consumers over the internet. These actions violate sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations include the sale of unapproved versions of tapentadol and tramadol, both opioids, and alprazolam, a benzodiazepine. These drugs are marketed without FDA-approved applications, posing significant public health risks. The availability of these substances online exacerbates the opioid epidemic and the misuse of benzodiazepines, which are often co-used with other substances, leading to severe medical outcomes.

The FDA emphasized that unapproved drugs lack assurances of safety and effectiveness, potentially being contaminated or counterfeit. The agency requires USA Quick Meds to cease the sale of these unapproved and misbranded drugs immediately to protect consumers.

The regulatory framework mandates that new drugs must have FDA approval before being marketed in the U.S. The FDA"s actions aim to mitigate the risks associated with the nonmedical use of these potent drugs, which can lead to addiction, abuse, and life-threatening conditions. USA Quick Meds is instructed to comply with these regulations to prevent further violations and ensure public safety.

Company
www.usaquickmeds.com
Inspection date
August 19, 2025
Product type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Sangeeta V. Chatterjee
View Company Profile

ID · 2f3ab92e-8223-42f7-beb8-83cd193ca411

Violation Codes10
21 U.S.C. 353(b)(1)21 U.S.C. 321(g)21 U.S.C. 331(a)21 U.S.C. 331(d)21 U.S.C. 352(f)(1)21 CFR 201.12821 CFR 201.115(a)21 U.S.C. 331(k)21.U.S.C. 355(a)21 U.S.C. 321(p)

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