The FDA has castigated Novartis for what it calls ‘significant violations’ of current good manufacturing practice (CGMP) regulations for finished pharma products.
In a strongly-worded warning letter the US regulator says its inspectors identified a variety of problems at the company’s manufacturing facility in Unterach am Attersee, Austria.The FDA believes Novartis subsidiary Sandoz has not taken account of written and verbal instructions from the regulator not to release some vials of a product, because they had particles visible in them.
It adds that at least ten vials did make it to market, and suggests this means the company’s visual inspections are not ‘robust enough’.
“The procedures established to perform the visual inspection of critical defects, such as particulate matter in finished parenteral drug vials, are inadequate in that operators following these procedures have repeatedly failed to detect visible particles,” the FDA insists.
The regulator wants distribution information for all those lots, plus a risk assessment for allowing them to remain on the market and a wider commitment to audit current production procedures. (Más)
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