FDA monitoring Australian influenza vaccine producing facility

The U.S. Food and Drug Administration released a copy of a June 28 letter sent to CSL Biotherapies, the operators of an Australian influenza vaccine producing facility, detailing irregularities there.

The Center for Infectious Disease Research and Policy reported that the facility, which manufactures Alfluria and a monovalent 2009 H1N1 vaccine for the U.S. market, was cited for what the FDA has called, “deviations from current good manufacturing practice requirements.”

CSL has been accused of not conducting a rigorous enough investigation into unknown particles that had been found in multi-dose vials of Alfluria. The allegations stem from an April 19 to April 28 FDA inspection of the facility in Parkville, Victoria, Australia.

The CSL led investigation allegedly did not demonstrate that corrective and preventative measures were available, and did not look into the potential that the particles were caused by interactions between the vaccine itself and the vial or stopper that was used in its storage.

The FDA also stated that CSL was continuing to utilize a specific type of stopper on multi-dose vials that contain thimerisal, a preservative, despite warnings that an unwanted interaction could occur. The FDA also determined that CSL did not properly test samples from its vaccine lots annually for deterioration.

According to Reuters, CSL asserted that the FDA concerns are unrelated to an outbreak of higher-than-normal rates of fevers and convulsions among Australian children treated predominantly with Fluvax.