Four months into the FDA’s new enforcement initiative, the agency has issued its first closeout letter. The agency sent Novalis Integra the letter to close out an Oct. 8 warning letter citing the company for marketing unapproved influenza A (H1N1) products. The FDA evaluated Ottowa-based Novalis Integra’s corrective actions to address violations cited in the warning letter, the closeout letter says. The new closeout process was announced Aug. 6 by FDA Commissioner Margaret Hamburg.
Drug Industry Daily