CRN Launches New Tool To Help Industry Monitor, Analyze and Learn From Violations
Thank you for your interest in CRN’s FDA Warning Letters database. To get the most out of the available data, it helps to have a basic understanding of how the Warning Letter process works. Some Warning Letters are issued following a dietary supplement GMP inspection, and after FDA has given the inspected company time to respond to alleged violations that were observed during the inspection. If the company’s initial response was inadequate, FDA may issue a Warning Letter. Often, FDA may take a sample of product labeling during inspection and send the company a Warning Letter if the labeling is found to make claims that cause the products to be misbranded or if the labeling violates the Food, Drug and Cosmetic Act, such as failing to follow the detailed requirements for the “Supplement Facts” label or absence of a domestic address for reporting of serious adverse events.
Warning Letters may also be issued after FDA evaluates a company’s website and finds claims (often drug claims) that cause the products to be misbranded. Additionally, FDA sends Warning Letters to companies that market products containing a dietary ingredient that does not have a New Dietary Ingredient notification but should.
Companies have 15 days to respond to a Warning Letter. If a company does not respond within 15 days, FDA may exercise other enforcement authorities, such as injunctions, mandatory recalls or seizures.
Many times, companies will resolve the issues cited in the Warning Letter, however, Close-out Letters are not posted as regularly as Warning Letters on FDA’s website. The absence of a posted Close-out Letter does not necessarily mean one does not exist. CRN’s database includes the information that is currently available from the agency.
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