We help companies develop adverse event reporting and record keeping procedures to comply with the laws and FDA regulations. These processes and their documentation are vital to ensuring that manufacturers and marketers meet federal rules. Our services include customized documentation and education on how to create and maintain proper records.

Those processes include handling adverse event reports from consumers. While Section 403(y) of the Federal Food, Drug, and Cosmetic Act does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

How does a company respond to a letter or phone call? Our consultants construct processes for information capture and retention. We also analyze communications processes to determine if information is being routed to the proper departments for immediate action.

Following food recalls and health warnings in 2008 and 2009, the FDA is putting increased emphasis on quick response to consumer health problems relating to product contamination and spoilage. Companies that fail to act promptly on adverse event reports face investigation and possible fines from the FDA. Therefore, they need to have reliable processes in place to detect problems.