Warning Letters
FDA WARNING LETTERS

FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in patients.

FDA routinely scans websites in the United States and around the world, as well as product labels, other labeling and promotional materials to ensure that companies are not representing their products as safe and effective for COVID-19, use for which they have not been approved by FDA and that they do not make claims that misbrand the products in violation of the FD&C Act.

If your company is not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States.

MOST RECENT FDA WARNING LETTERS

We advise you to review your websites, product labels, and other labeling and promotional materials. Otherwise, your company will probably receive one of the following letters, before or after an FDA inspection.

Failure to immediately correct the violations cited in these letters may result in seizure and injunction, without further notice.

Foreign Supplier Verification Program (FSVP)
Your company failed to conduct a hazard analysis as required, develop, maintain, and follow a FSVP. Verification activities under FSVP may include reviewing food safety records, onsite inspections, testing and sampling shipments of imported products, among other appropriate supplier verification activities.

Adulterated/Misbranded Dietary Supplements
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

Unapproved Drugs and Labeling Compliance
Unapproved and Misbranded Products Related to Coronavirus Disease 2019.
Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (COVID-19).

Manufacturing Quality
CGMP/Finished Pharmaceuticals, Active Pharmaceutical Ingredients (APIs)/Adulterated.

Prescription Drug Promotion

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