CSL Biotherapies gets official warning letter from US FDA

The US Food and Drug Administration issued a formal warning letter to Australia’s largest biotech firm CSL Biotherapies, a division of CSL Ltd (ASX: CSL), after finding deviations from current Good Manufacturing Practice (CGMP) requirements in the manufacture of the company’s licensed biological vaccine Afluria and monovalent influenza bulks at its Parkville, Australia, facilities.

The warning letter relates to the FDA’s most recent annual inspection of CSL Biotherapies’ influenza vaccine manufacturing facilities, processes and procedures at the Parkville site, in March 2011. “You should take prompt action to correct these deviations,'' writes compliance director Mary Malarkey, warning: “Failure to promptly correct these deviations may result in regulatory action without further notice. Such action may include licence suspension or revocation.”

Linked to convulsions and fevers in children

In June last year, CSL withdrew the vaccine, sold as Fluvax in Australia, for use on children under the age of five after it was linked to convulsions and fevers. However, reports the Sidney Morning Herald, the company has yet to discover why the side effects were far more common in young children vaccinated with Fluvax than those who used other brands.

At the completion of the March inspection, the FDA issued CSL Biotherapies with a list of observed deviations from Practice cGMP). CSL Biotherapies submitted a written response to the FDA to address the observations, including details of corrective steps that had already been undertaken as well as further actions underway.