# FDA WARNING_LETTER - Chen-Yu Ou - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/chen-yu-ou/cb17b700-8e34-4ddf-b36f-62565894369c

> FDA WARNING_LETTER for Chen-Yu Ou on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Chen-Yu Ou
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to the operators of 366rx.com, rxabode.com, and rxcart.com for offering unapproved and misbranded drugs for sale, violating the Federal Food, Drug, and Cosmetic Act.

The identified violations include the sale of "Xanax (Generic)," "Valium (Generic)," "Viagra (Brand)," "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Herbal Xanax," and "Herbal Viagra." These products are classified as drugs under section 201(g) of the Act due to their intended use in diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function.

Specifically, "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Herbal Xanax," and "Herbal Viagra" are unapproved new drugs under section 201(p) of the Act. Rimonabant (Acomplia) was previously rejected for FDA approval due to safety concerns, including neurological and psychiatric side effects. The sale of these unapproved drugs violates sections 301(d) and 505(a) of the Act.

Furthermore, products like "Xanax (Generic)," "Valium (Generic)," and "Viagra (Brand)" are misbranded under section 503(b

## 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/chen-yu-ou/cda27d1a-d2f6-4d39-8771-a3f089ea5414

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