CSL vaccine plant cited in FDA letter
pharmafile | July 1, 2010 | News story | Manufacturing and Production |Â Â CSL, GMP, P&G, manufacturing complianceÂ
CSL Biotherapies has been sent a letter by the US Food and Drug Administration which indicates that vials of seasonal and pandemic flu vaccines produced by the Australian company showed discoloration with dark particles.
There is no suggestion that the quality compliance problems are related to CSL’s withdrawal from the market of paediatric seasonal flu vaccine Fluvax Junior last month. That action was taken after a nine-fold increase in fever and convulsions was observed among children receiving the shot.
The ‘untitled’ letter from the FDA, dated June 24, indicates that an inspection of CSL Biotherapies’ manufacturing facility in Melbourne during April revealed deviations from Good Manufacturing Practice (GMP), including a failure to investigate why failed batches met specifications.
In FDA parlance an untitled letter is the initial correspondence with a company used to cite violations found during an inspection that are not serious enough to warrant a full-blown warning letter.
CSL also failed to ensure that drug product container components did not react with substances contained in the vaccine products or examine retained samples for periodic inspection for deterioration, according to the latter, which can be downloaded here.
It also raises issues with the testing procedures used by CSL to test components of its vaccine products for strength, quality and purity.
The company maintains that the particles are discoloration and not related to any contamination issues, but says it will work closely with the FDA to correct the violations.
Products made at the plant include the trivalent seasonal influenza vaccine Afluria and monovalent H1N1 pandemic flu vaccine Panvax.
– Meanwhile, Procter & Gamble has issued a US-wide recall of its VapoSpray 4 Hour Nasal Spray (oxymetazoline HCl) because some formulations may not tally with the printed expiration dates on the packaging. Last year, the company issued a recall for the same product in the US, Germany and the UK after bacterial contamination was seen in samples made at a plant in Germany.
Phil Taylor
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