sandra-pharma.is

Warning LetterOpen

sandra-pharma.is United StatesIssued Jan 28, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateJan 28, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: sandra-pharma.is
Location: sandra-pharma.is United States
FEI Number: N/A
Country: United States
Issue Date: January 28, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Sandra-pharma.is sold unapproved new drugs and misbranded drug products intended to mitigate, prevent, treat, diagnose, or cure COVID-19 over the internet to U.S. consumers, violating sections 505(a) and 502 of the Federal Food, Drug, and Cosmetic Act. The company's products lacked FDA approval or authorization and did not carry the same safety and effectiveness assurances as FDA-regulated drugs. This enforcement action was undertaken during the declared public health emergency and national emergency related to COVID-19, when the FDA prioritized protecting consumers from unauthorized COVID-19 treatment claims.

sandra-pharma.is FDA Warning Letter, January 28, 2021