ARTICLE | Clinical News

Afluria regulatory update

July 4, 2011 7:00 AM UTC

CSL received a warning letter from FDA relating to deviations in cGMP practices in the manufacture of Afluria seasonal influenza vaccine and monovalent influenza bulks observed during a March inspection of the company's Parkville, Australia, site. The letter notes that CSL's response to the observations at the site did not provide sufficient details for FDA to fully assess the adequacy of the company's corrective actions and lists a number of significant items that require prompt attention. CSL said the problems identified in the letter primarily relate to the methodology used by the company to document and manage processes and investigations. FDA requested a meeting with CSL, which said it plans to "work diligently" with the agency to resolve the issues as quickly as possible. ...