Regulatory action against the Swiss pharma escalated late last year when three Sandoz plants were cited in a US Food and Drug Administration (FDA) warning letter and Novartis’ Nebraska site received a 483. Having re-inspected the Nebraska facility over the turn of the year the FDA sent a second 483.
In the 23-page 483 the FDA wrote: “Your firm is overdue with adequately conducting approximately 1,360 investigations you have received from consumer complaints.” The FDA criticised the backlog after its June inspection and this is one of seven repeat observations in this month’s 483.
Most of the repeat observations date back to last summer’s inspection but one is a longer-standing concern. During inspections in 2007, 2010 and 2011 the FDA found Novartis failed to extend its deviation investigations to other potentially affected batches.
“It is important to understand because of your firm’s failure to adequately and thoroughly conduct investigations, it is difficult to determine how widespread the problems are at your firm”, the FDA wrote.
Over six pages the FDA gives “just a few examples of numerous instances” of this occurring. Examples include various tablets being found on different parts of production lines after major cleans of the equipment.
12 extra tablets
The FDA also gives an example of ’12 extra tablets’ being found in a bottle of morphine sulphate. A pharmacist alerted Novartis but, according to the FDA, the company failed to document a root cause for the defect, identify the tablets, or take preventive measures to put a stop to the problem.
“This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints”, the FDA wrote. The Agency gave more examples of how Novartis was handling its backlog of complaints, 31 of which are regarded as critical.
Consumer complaints include reports of different types of drug being found in the same packet. From January 2009 to June 2011 Novartis evaluated 398 foreign product complaints. In November Novartis closed the investigation and the FDA is critical of how it handled the cases.
“Your firm has been aware of multiple mixed product complaints since at least 2009, yet a complete market correction was not executed until January 8, 2012, which occurred during the course of this FDA inspection”, the Agency wrote.
Resuming shipments
Novartis expects to resume shipments from the plant in mid-2012. Speaking after Novartis’ fourth quarter results last week, Joe Jimenez, CEO of Novartis, said: “We have dedicated teams working on remediating those issues and getting the site back up.”
The facility manufactures over-the-counter Novartis products, such as Excedrin and Prevacid, and generates annual sales of $1bn (€760m). In 2011 Novartis posted net sales of $58.6bn.