FDA posts warning letter sent to Novo over semaglutide marketing

In a warning letter to Novo Nordisk (NVO) regarding its Plainsboro, NJ plant, the FDA said, “Specifically, you and your contractors inappropriately invalidated 15-day Alert reports due to a lack of patient identifiers; however, during the inspection, FDA identified valid patient identifiers in source documents for these reports. These reports were not submitted to FDA until they were discussed with you during the inspection. For example, Argus case 1342548 includes a consumer reporting a death for a male patient who received semaglutide, however you invalidated the case because you failed to capture the patient identifier. During the inspection, FDA found the patient identifier in the source documents for this case. As a result of this erroneous invalidation, you failed to report serious and unexpected ADEs to FDA within 15 calendar days as required.”