# FDA WARNING_LETTER - Orion Star & Associates Inc. - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/orion-star-associates-inc/48b21aab-97cc-4a22-881f-e234aec67236

> FDA WARNING_LETTER for Orion Star & Associates Inc. on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Orion Star & Associates Inc.
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to the operators of i-want-rx.com, refill-online.com, ultra-rx.com, trust-pharm.com, trust-european-pharmacy.com, pill-planet.com, and pharmacy-usa.biz for offering violative drug products for sale. The products, including "Acomplia (Brand/Generic)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," are considered drugs under section 201(g) of the Act.

The violations include marketing unapproved new drugs, specifically "Acomplia" and "Rimonabant," which were rejected for FDA approval due to safety concerns like neurological and psychiatric side effects. Selling these without FDA-approved applications violates sections 301(d) and 505(a) of the Act.

Additionally, many products, such as "Viagra," "Cialis," "Prozac," and "Levitra," are sold without requiring a prescription from a licensed practitioner, rendering them misbranded under section 503(b)(1) and violating sections 301(a), 301(b), and 301(k). The websites also falsely claim FDA approval for their products, making them misbranded under section 502(a) due to false and misleading labeling

## 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/orion-star-associates-inc/d83aabb9-2d43-4634-83ff-74609c7f5dcb

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