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Posted 24 August 2012 | By Alexander Gaffney, RAC
Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues.
The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue.
EMA officials said they had inspected Pacira's San Diego-based DepoCyte facility in July 2012, where they found, "Deficiencies in the manufacturing process of DepoCyte, relating to a lack of adequate sterility assurance."
Though officials said they have not confirmed any instances in which a non-sterile DepoCyte product has reached patients, they said the findings posed a "theoretical risk of sterility failure," and were recommending EU Member States recall the drugs if alternate treatments were available. In countries where no alternative exists, regulators said the drug may still be used, but should have close patient monitoring to ensure no unexpected adverse events occur.
Until EMA regulators have re-inspected the plant, new batches of DepoCyte will not be manufactured or released, EMA said.
Pacira did not have any statement available on its website.
Tags: Sterility, Latest News, Inspection, GMP