# FDA WARNING_LETTER - beststeroidstore.net - September 10, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/beststeroidstorenet/762bbfb0-06ef-473e-935c-3dc4c4db306e

> FDA WARNING_LETTER for beststeroidstore.net on September 10, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: beststeroidstore.net
- Inspection Date: 2020-09-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to www.beststeroidstore.net for offering unapproved and misbranded opioid products, specifically "Tramal-SR" (Tramadol 100mg By Searle Pharma Blister), for sale to U.S. consumers via their website. This violates sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The product is an unapproved new drug under sections 201(g) and 201(p) of the FD&C Act because it is intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function, and is not generally recognized as safe and effective. No FDA-approved applications exist for this specific Searle Pharma product. FDA-approved tramadol carries a "black box warning" due to risks like addiction, abuse, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the product is misbranded under section 502(f)(1) of the FD&C Act because it lacks adequate directions for use by a layperson. As a prescription drug, it requires professional supervision for safe use, and adequate directions cannot be provided for self-treatment.

The FDA demands immediate cessation of violative drug sales to U.S. consumers. The company must

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Company: https://www.globalkeysolutions.net/companies/beststeroidstorenet/191e2471-cd04-4201-a7c0-7ec42b6453bb

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c