Hospira hit with Canada import ban over data integrity concerns
The ban covers all non-medically necessary products made at the site, which includes a range of own brand nausea treatments and the injectable vitamin supplement Calcijex that Hospira produces for AbbVie.
Several drugs made at the site are not covered by the ban – including the injectable monoclonal antibody-based respiratory syncytial virus (RSV) vaccine Synagis (palivizumab) that Hospira makes for AbbVie – on the basis that they are medically necessary.
The ban follows just a few weeks after the US Food and Drug Administration (FDA) issued the Liscate facility with a warning letter detailing a range of concerns, including that software on HPLC systems used at the site lacked “sufficient controls to prevent the deletion or alternation of raw data files.”
Health Canada did not explicitly say the US FDA letter had prompted the ban, instead citing the actions of a “trusted regulatory partner” as the motivation.
The regulator said: “The licences of Canadian companies that import drugs from this facility are being amended with terms and conditions that require independent third-party testing against the approved Canadian specifications prior to release of any medically necessary products to the Canadian market.”
Health Canada also said that: “Independent, third-party testing will provide confidence that the affected medically necessary products meet Canadian quality standards before being released for use by Canadians.”
The ban comes as Pfizer works to complete its $17bn acqusition of Hospira.
