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Novartis receives FDA warning

Published on 06/06/13 at 02:14pm
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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.

Novartis and its generics division will also have to provide an action plan to address each discrepancy identified by the audit as well as “specific corrective actions your firm is implementing to ensure adherence to application commitments in the future, as well as proper evaluation and handling of proposed changes to them”. 

It all adds up to quite a charge sheet - and if the FDA is not satisfied with the response then it could refuse permission for products manufactured at Unterach to be allowed into the US.

While Novartis and Sandoz insist that there is no cause for alarm in terms of any product supply chain issues at present, it says it is aware of the gravity of the FDA’s observations, which were made following a visit in October last year.

“We take seriously the warning letter observations cited by the FDA and will work closely and expeditiously to address these concerns to the agency’s full satisfaction,” said Ameet Mallik, Sandoz’s head of biopharmaceuticals & oncology injectables.

Novartis and Sandoz took responsibility for the facility after the acquisition of EBEWE Pharma in 2009, and say they are “not aware of any adverse events in products manufactured at the Unterach site associated with the observations in the letter” since 2011.

“Sandoz has made strong progress in strengthening operations in Unterach through significant investments in both resources and state-of-the-art technologies,” Mallik went on. “We remain deeply committed to fully addressing all outstanding issues and meeting all quality standards.”

Novartis has only to look at the problems it has experienced in the US to remind itself of the potential cost of such manufacturing woes.

Issues at the company’s plant in Lincoln, Nebraska blew a $200m hole in the accounts in the first quarter of 2012 in lost sales and other charges.

Adam Hill

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