# FDA WARNING_LETTER - sandra-pharma.is - January 05, 2021

Source: https://www.keypedia.com/records/warning_letter/sandra-pharmais/1d0f2df5-b72c-46cc-b1ef-b15c26db05f2

> FDA WARNING_LETTER for sandra-pharma.is on January 05, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: sandra-pharma.is
- Inspection Date: 2021-01-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 28, 2021, the FDA issued a Warning Letter to www.sandra-pharma.is following a website review on January 5, 2021. The FDA observed the website offering drug products for sale in the U.S. that claim to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like "infections."

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], and misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352]. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act [21 U.S.C. § 331(a) and (d)].

Specifically, the website offered "Plaquinol 400mg" (hydroxychloroquine) and "Azitromicina Aurovitas 500mg" (azithromycin) as "COVID 19 Treatment 10+3 Tabs," claiming they "cure Covid 19 patients." While FDA-approved versions of these drugs exist, the products offered by sandra-pharma.is lack FDA approval and

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.keypedia.com/companies/sandra-pharmais/f5b5eed7-1803-45e5-972e-9e1926d22f55

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