Wednesday, September 28, 2011
Aussie Company Faces FDA Accusation about Manufacturing Practices
udits carried out by the FDA in 2010 and 2011 revealed "objectionable conditions and practices" within CSL, the privatised Commonwealth Serum Laboratories, News Limited reported on Thursday.
Allegations include that CSL took six months to start investigating the cause of dark particles in the national stockpile of swine flu vaccines.
The FDA's most recent audit, carried out in March, found CSL's investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine, was "inadequate".