US Watchdog lashes pharmaceutical giant CSL over lab practices

US Watchdog lashes pharmaceutical giant CSL over lab practices









SECRET audits by the powerful US Food and Drug Administration
have revealed a multitude of manufacturing flaws at Australia's biggest
pharmaceutical company, CSL. The FDA's 2010 and 2011 audits, released
to The Australian yesterday after a Freedom of Information request,
cite a string of "objectionable conditions and practices" used by CSL
to make vaccines.

The FDA allegations - which CSL said yesterday had been or were in the
process of being resolved - include the failure of laboratory staff to
wear masks while dispensing and mixing vaccines, "deficient" tests to
check whether viruses were properly split to prevent side-effects and
"inadequate" investigations into product failures.

The FDA documents reveal that CSL took six months to start
investigating the cause of mysterious dark particles in the national
stockpile of swine flu vaccine.

The most recent audit, in March, branded as "inadequate" CSL's
investigation of febrile fits among children immunised with Fluvax, its
seasonal flu vaccine.

Eleven months after Fluvax was banned for young children, the FDA audit
discovered CSL had not compiled an investigations report or even
designated anyone to be in charge of the investigation.









Australia's
pharmaceutical regulator, the Therapeutic Goods Administration, refused
to release the findings of its own audits into CSL.

And CSL insisted the FDA audits contained "observations only" rather than any final determination of compliance.
CSL, the privatised Commonwealth Serum Laboratories, has also been
under fire this week after being forced to ration supplies of
penicillin in its role as sole Australian supplier of the medicine.

The FDA audit findings form the basis of a "warning letter" the US
regulator sent to CSL in June, threatening to revoke its US licence if
it failed to address outstanding issues.

This year's audit described as "inadequate" CSL's investigation into
the high rate of fever and convulsions among children given the Fluvax
shot last year. "There was limited analysis of the manufacturing
process to determine why there was a substantial increase of
adverse-event reports of fever and convulsions in the 2010 southern
hemisphere influenza season in comparison to previous seasons. "There
was no evaluation of testing of raw material and potential impact on
manufacturing," it said.
The audit found 15 lots of a key ingredient in CSL's flu vaccines, the
detergent sodium taurodeoxycholate, failed an "identity test" but were
used regardless.

The detergent is used to split the flu viruses used to make vaccines to minimise side-effects.
The Medical Journal of Australia reported last week that CSL was "one
of only a few manufacturers globally" to use the ingredient.

The FDA audit also criticised CSL's "inadequate" investigation into the
cause of dark particles that appeared in multi-dose vials of vaccines
against swine and seasonal flu, produced for the US market in 2009.
"The investigation is ongoing and a root cause has not been determined,"
its report said.

It also noted that CSL had manufactured products "outside the validated
processes" without determining if they would remain stable until their
expiry date.

It cited a "formulation error" discovered in July last year, when not
enough swine flu virus was used in the vaccine against seasonal flu.

The FDA inspectors raised the problem of black particles in multi-dose
vials during an inspection of the Parkville laboratory in April last
year.

The same discolouration had been detected in Australia's stockpile of
swine flu vaccine, Panvax, for which the federal government paid CSL
$131 million of taxpayer funds. Half the stockpile - 10 million doses -
had to be destroyed after passing their use-by date last year, while
the paediatric version was withdrawn early because the medication lost
potency before the expiry date.

The FDA's 2010 audit found CSL's supplier of rubber stoppers had told
the company they could react with the mercury in multi-dose vials and
should not be used.

The TGA said it agreed with the FDA findings, but it refused to release its own audits.



Source:-
http://www.theaustralian.com.au/business/companies/us-food-and-drug-administration-lashes-pharmaceutical-giant-csl-over-lab-practices/story-fn91v9q3-1226150436184