Regulators warn firm in face of repeated violations
Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration (FDA) over failings at one of its manufacturing plants.
The FDA letter accuses Sandoz of distributing medicines without FDA marketing authorisation, after inspectors found visible particulate contaminants in injectable medicines at the plant in Unterach am Attersee, Austria, in 2012.
The FDA could now withhold approval for any new products from Sandoz or Novartis, as well as block imports of products manufactured at the Austrian plant, until the matter is resolved. Sandoz has said in a statement that it is taking the FDA’s observations seriously, but since it has not received reports of any adverse events relating to these medicines, it does not anticipate any supply problems.