Company: Sandoz, Novartis generics division
Plants: Broomfield, CO; Wilson, NC; Boucherville, Quebec, Canada
Warning letter: Nov. 18, 2011
Sandoz is the generics division of Novartis, whose OTC division has its own quality problems, but its three-plant warning letter and the fallout from having to stop some production at its plant in Canada, make it a case unto itself.
The Canada plant reduced production and started remediation in February, then a small fire complicated work. The plant makes more than half of the hospital injectable drugs used in Canada, including cancer drugs that are considered essential. The shortages have put members of Parliament up in arms and started efforts to legislate some requirements for drugmakers there. Sandoz Canada's Michel Robidoux had to grace the House of Commons and tried to explain that the company was still meeting most of the demand.
The warning letter for the plant suggests some deep-rooted issues. The Canada plant reported inconsistent numbers between vials filled and incubated and failed to figure out why a batch of injectables released to the U.S. had crystallization. Broomfield had the same kind of investigation issues, equipment that was not clean, and lacked procedures to guarantee drugs met purity and strength criteria. Ditto on the last one for the North Carolina plant.
Investigators seemed particularly ticked off that some of the violations were repeats noted in earlier inspections. "It is apparent that Novartis International AG (Novartis) is not implementing global and sustainable corrective actions," the FDA noted.