Two Apotex facilities cited by FDA
pharmafile | March 25, 2013 | News story | Manufacturing and Production |Â Â Apotex, FDAÂ
Canadian generic drugmaker Apotex has been sent another warning letter by the FDA after violations were uncovered at two manufacturing facilities.
The warning letter says that Apotex failed to follow procedures to ensure supposedly sterile products made at its plant in Toronto were free from microbiological contamination, including “validation of all aseptic and sterilisation processes”.
The Toronto facility was also help up for not exploring the reasons for batch failures and making sure product from out-of-specification batches did not get released into the supply chain, which was a repeat offense from earlier inspections in 2010 and 2009.
The FDA said it was concerned generally about Apotex’ ‘approach to process validation’, referring to cases in which tablets lacked the required hardness.
The second facility in Richmond Hill, Ontario, was also upbraided for its handling of batch quality failures, including after sterility testing. It also failed to keep adequate lab records to maintain “compliance with established specifications and standards”.
The latest warning letter continues a long-running battle between the FDA and Apotex, which sued the agency last year over an import alert that it claimed cost it around $520m, and was harsher than the penalty applied to other companies with similar issues.
Apotex said it responded to the FDA’s latest round of concerns earlier this month.
Jubilant HollisterStier site also pulled up
Meanwhile, the FDA is also concerned about another Canadian facility, this time operated by Jubilant HollisterStier in Kirkland, Quebec.
A warning letter on the FDA’s website indicates that the sterile injectable facility also has issues with out-of-specification product being released for distribution, and a lack of investigation into the root cause of batch failures.
The FDA has been tightening up its oversight of generic firms of late, particularly those making sterile injectable products that have been plagued by shortages, as a consequence of the increased resources available thanks to the Generic Drug User Fee Amendments (GDUFA) of 2012.
Phil Taylor
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