FDA Warning Letter Cites Novartis Plants

The letter follows inspections between April and August this year, which uncovered ‘significant violations’ of cGMP regulations, including microbiological contamination of drug products purporting to be sterile.

The US FDA has sent a warning letter to Novartis about a failure to meet GMP standards at three North American manufacturing facilities operated by its generics subsidiary Sandoz.

The letter follows inspections between April and August this year, which uncovered ‘significant violations’ of cGMP regulations, including microbiological contamination of drug products purporting to be sterile. It also criticises Novartis’ senior management for not ensuring ‘adequate, or timely resolution of the issues’.

The plants cited in the letter include two in the US at Broomfield, Colorado, and Wilson, North Carolina, in addition to one in Canada at Boucherville, Quebec.