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Posted 24 January 2014
In the US, a massive and deadly outbreak of fungal meningitis in 2012 prompted regulators to take a close look at compounding pharmacies, ultimately finding that many made products using procedures that did not meet federal standards for good manufacturing practices.
Now France may be on the cusp of starting some regulatory soul-searching of its own after the deaths of four newborns were linked to parenteral nutrition bags made by a small manufacturing laboratory, Pharmacie Marette.
Reports of the infant deaths had first come to the attention of ANSM, the French healthcare product regulator, on 16 December 2013 through a local department of health. ANSM said it quickly determined that all four had received products made at the same pharmacy, Marette, and it moved to withdraw all existing stock of its products from circulation.
ANSM then raided the pharmacy's facilities on 17-19 December, where it found evidence of bacterial contamination. "This inspection resulted in the recognition of manufacturing conditions that did not meet all the strict Good Manufacturing Practices," the regulator wrote. This finding caused ANSM to suspend the facilities' operating licenses, though it said it is still unable to prove if those deficiencies definitively caused the contamination in the IV packets given to the four deceased infants.
At least two other patients had received the products and developed infections as a result, ANSM said. Both survived and recovered.
The episode is similar in some respects to the 2012 meningitis outbreak. It remains to be seen, however, if ANSM will probe more pharmacy manufacturers to assess compliance with GMPs.
In the US, after tracing contaminated product back to a compounding pharmacy in Massachusetts, FDA significantly ramped up its inspections of US-based compounding pharmacies. It ultimately issued dozens of FDA Form 483s notices indicating significant deficiencies.
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Tags: France, EU