# FDA WARNING_LETTER - Hunter, D - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/hunter-d/f66d3d00-ab1d-4ef3-b0c1-bc19f588653c

> FDA WARNING_LETTER for Hunter, D on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hunter, D
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to medspricedright.com and valuedrugspharmacy.com for offering violative drug products for sale. The products include "Acomplia (Brand)," "Rimonabant," "Herbal Ambien," "Ambien (Brand)," "Valium (Brand)," and "Xanax (Brand)."

The identified violations include the sale of unapproved new drugs. "Acomplia (Brand)" and "Rimonabant" are unapproved new drugs under sections 201(p) and 505(a) of the Act, 21 U.S.C. §§ 321(p) and 355(a), as Rimonabant was rejected for FDA approval due to safety concerns. "Herbal Ambien" is also an unapproved new drug under section 201(p) of the Act. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).

Additionally, the websites are selling misbranded drugs. "Ambien (Brand)," "Valium (Brand)," and "Xanax (Brand)" are offered without requiring a prescription from a licensed practitioner, violating section 503(b)(1)

## Related Officers

- [Director, Office of Compliance, Center for Drug Evaluation and Research](https://www.keypedia.com/people/director-office-of-compliance/e953bab9-1117-40df-ad88-bc71ab913623)

Company: https://www.keypedia.com/companies/hunter-d/368b6ce3-137a-4747-b7ae-3ffa263044d7

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