Two months ago, the FDA issued a warning letter for a Hospira ($HSP) plant in Italy noting a number of problems including its lack of controls for access to prevent data deletions from test equipment. Health Canada has decided that issue is enough for it to ban products coming out of the sterile manufacturing facility.
The regulator, which has followed the FDA's lead on a number of facilities lately, said Monday that it is banning all products coming out of the Hospira plant except those that are deemed medically necessary. For those, it will require that distributors get an independent lab analysis to assure their integrity before they can be released, according to a Health Canada announcement. It has ordered importers to quarantine the rest of the products on its list.
Canada said the steps were taken "to help mitigate any potential risk in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site."
The FDA in late March issued the warning letter, which laid out a number of problems. It said that instead of carefully investigating 103 customer complaints that related to discoloration of an injectable drug, employees at the plant reached a conclusion about what caused it without even considering that it "might have been caused by the failure to perform a step in the manufacturing process."
It also noted the issues with data being susceptible to deletion because computer equipment was not protected from unauthorized use, an issue the FDA has become concerned with after finding that employees at some other companies' plants have done just that to hide batch failures. The company at the time the letter was issued said that it had been working on the matters addressed in it and had already resolved some of them.
The warning letter for the plant in Liscate is only one of several with which the Lake Forest, IL-based company is dealing. It also has been issued warning letters by the FDA for plants in the U.S., India and Australia. But those issues will soon be Pfizer's ($PFE) to deal with, since the Big Pharma player has struck a $17 billion deal to buy the sterile injectable specialist.
- here's the announcement