Investigation under fire
July 12, 2011
AUSTRALIAN manufacturer CSL
has been hit with a warning letter
from the US Food and Drug
Administration, over lapses in
current good manufacturing
practice requirements (CGMP).
The letter stemmed from an FDA
site inspection of CSL Biotherapies’
facility in Parkville, Victoria, in
March this year.
During the inspection FDA
representatives noted “deviations
from current good manufacturing
practice requirements in the
manufacture of licensed biological
vaccine Afluria and monovalent
influenza bulks”.
These deviations included CSL’s
“unsatisfactory” investigation
processes of post-manufacturing
deviations and adverse events,
regarding the adverse febrile
reactions that occurred in children
in April 2010.
According to the inspectors, CSL
had “no documentation of the
Adverse Event investigation,”
contrary to requirements.
The FDA also found there “was a
limited analysis of the
manufacturing process to
determine why there was a
substantial increase in Adverse
Event reports of fever and
convulsions in the 2010 Southern
Hemisphere influenza season in
comparison to previous seasons”.
Other examples of breaks in
CGMP noted by inspectors further
illustrated issues with the
methodology used by CSL to
manage its processes and
investigations, in particular the fact
that it does not thoroughly
investigate problems that are
detected.
The letter advised CSL that it
needed to address its deficiencies,
and that failure to respond within
15 days “may result in regulatory
action without further notice” and
that “...such actions may include
license suspension and/or
revocation”.
CSL has since responded to the
FDA addressing the observations,
including details of corrective
steps that had already been
undertaken as well as further
actions underway.
“We will work diligently with the
FDA to resolve these GMP issues as
quickly as possible while
continuing to fulfill our
commitments to public health
programs in Australia and
internationally,” ” said Dr Jeff
Davies, Executive Vice-President
CSL Biotherapies.
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