FDA Posts First Closeout Letter Under Its New Enforcement Initiative

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