The country’s largest pharmaceutical manufacturer, Commonwealth Serum Laboratories (CSL), has been accused of a string of bad manufacturing practices, including under-par laboratory safety and ignoring ‘dark particles’ forming in its swine flu vaccines.
The US Food and Drug Administration (FDA) conducted a series of audits over the past two years, which revealed the ‘objectionable conditions and practices’, according to Sky News.
CSL is reportedly working on resolving the issues, many of which occurred at the company’s Parkville, Victoria manufacturing facility.
One of the major revelations made by FDA was that CSL’s 2010 Southern Hemisphere seasonal influenza vaccine, Fluvax, was associated with increased reports of febrile events in children, compared to previous seasons.
The febrile events occurred predominantly in children under the age of five years, shortly after vaccination, said FDA.
Another problem was associated with CSL Biotherapies’ influenza vaccine manufacturing facilities, processes and procedures at the Parkville, Australia site.
Following an inspection of the facility in March this year, FDA issued a warning letter to CSL about a number of deviations from current Good Manufacturing Practice (GMP).
FDA said the major problem related to the methodology used by CSL Biotherapies to document and manage processes and investigations at its Parkville facility.