# FDA WARNING_LETTER - Randek l-warez - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/randek-l-warez/596d53dd-b607-4195-b3bf-0dbaf0778ae6

> FDA WARNING_LETTER for Randek l-warez on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Randek l-warez
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to thewomantour.com for offering violative drug products for sale, including "Xanax (Generic)," "Valium (Generic)," "Viagra (Brand)," "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," and "Herbal Ambien." The FDA determined these products are drugs under section 201(g) of the Act, intended for disease treatment or to affect body structure/function.

The firm is in violation of the Federal Food, Drug, and Cosmetic Act due to:
1.  **Unapproved New Drugs:** Products like "Acomplia (Brand/Generic)," "Rimonabant," and "Herbal Ambien" are unapproved new drugs. Rimonabant (Acomplia) was specifically rejected by the FDA due to safety concerns (neurological/psychiatric side effects). "Herbal Ambien" is also considered an unapproved new drug. Introducing these into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act.
2.  **Misbranded Drugs:**
    *   Selling prescription drugs such as "Xanax (Generic)," "Valium (Generic)," and "Viagra (Brand)" without requiring a prescription from a licensed practitioner violates section 503(b)(1) and sections 301(a

## Related Officers

- [Former FDA Deputy Commissioner](https://www.keypedia.com/people/deborah-m-autor/b16e4745-566a-4102-ae98-d314ad1b61f5)

Company: https://www.keypedia.com/companies/randek-l-warez/0824887d-459f-4a85-87c7-df1538fda7b5

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