Divyata – FDA Warning Letter, Sep 6, 2019

The FDA and DEA issued a Warning Letter to Divyata on September 6, 2019, for unlawfully selling opioids and other drugs to U.S. consumers via the internet.

**Violations and Deficiencies:**

* **Unlawful Distribution of Controlled Substances:** Divyata is operating as an "online pharmacy" without a modified DEA registration, violating the Ryan Haight Online Pharmacy Consumer Protection Act (RHA), specifically 21 U.S.C. § 841(h) and § 843(c). This includes offering to deliver, distribute, or dispense controlled substances and advertising their sale without proper authorization. * **Unapproved New Drugs:** Divyata introduces unapproved new drugs, such as "Tramadol (Ultram) 100 mg" by "Dimedics," into interstate commerce, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(d), 355(a)]. These drugs lack FDA approval and are not generally recognized as safe and effective for their labeled uses. * **Misbranded Drugs:** The tramadol product is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f