# FDA WARNING_LETTER - Divyata - September 06, 2019

Source: https://www.keypedia.com/records/warning_letter/divyata/bdbd326c-2f5c-4936-87c8-42844a903b15

> FDA WARNING_LETTER for Divyata on September 06, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Divyata
- Inspection Date: 2019-09-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Deputy Assistant Administrator](https://www.keypedia.com/people/neil-doherty/cb2d404a-984a-4ad6-b8a8-647bb234b06e)

Company: https://www.keypedia.com/companies/divyata/7cc4fca6-a08c-4ae3-a2ed-4e86daad5331

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