Novo Nordisk's U.S. headquarters faces FDA scrutiny in latest regulatory action Novo Nordisk’s U.S. headquarters in Plainsboro, New Jersey, has been issued a formal FDA warning letter following an inspection that uncovered compliance issues related to postmarketing adverse drug experience (PADE) reporting. The agency’s findings, detailed in the letter, highlight gaps in the company’s procedures for tracking and reporting side effects of its medications, including Ozempic and Wegovy. Novo acknowledged the letter in a public statement, emphasizing its commitment to addressing the concerns and resolving the issues with the FDA. The FDA’s inspection of the Plainsboro site, which serves as Novo’s U.S. operations hub, took place from January 13 to February 7, 2025, as part of a review of the company’s adherence to PADE regulations. During the inspection, the agency identified multiple shortcomings in Novo’s processes for monitoring and reporting adverse events. These included delays in submitting reports to the FDA, the ability to reject or cancel received reports, and insufficient medical review timelines for evaluating adverse events. The FDA also criticized Novo for failing to thoroughly investigate the root causes of these issues, raising concerns about the company’s ability to ensure product safety. In response, Novo stated it has implemented corrective and preventive action plans and has submitted seven updates to the FDA since the initial Form 483 notice was issued on February 7, 2025. The company argued that the warning letter primarily seeks additional details to confirm its compliance efforts and does not reflect any assessment of the quality or safety of its drugs. Anna Windle, head of clinical development at Novo Nordisk U.S.#fda #novonordisk #ozempic #wegovy #plainsboro_new_jersey
