FDA has sent an Untitled Letter to Australia’s CSL Biotherapies over issues at its Parkville, Victoria facility. The problems relate to particles found in product vials and the site’s inability to establish proper corrective action.
The letter states that CSL did not “document such that there is traceability of the corrective and preventative actions from the identification of problems to implementation of solutions and the follow up to evaluate effectiveness.” The letter continues: “. . . interaction between product and vial and/or stopper was identified as a potential root cause of the particle formation. This interaction has not been evaluated so as to rule it out as a potential root cause, even though notification was received of this potential interaction on December 17, 2009 by the stopper supplier.”
Further, CSL “failed to assure that drug product containers or closures are not reactive and additive so as to alter the safety, identity strength, quality and purity of the drug beyond the official or established requirements [21 CFR 211.94(a)].” For example, FDA notes, “stoppers may react with thimerosal and therefore are not recommended for use with thimerosal containing products. To date your firm still utilizes these stoppers for MDV’s of vaccine containing thimerosal.”
For a copy of the FDA letter, read here.