FDA cites violations at three Novartis plants
Tue Dec 6, 2011 3:14pm EST
(Reuters) - Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses.
U.S. Food and Drug Administration investigators found a lack of proper procedures to ensure the drugs' sterility and correct composition. They also found inadequate cleaning at one of the plants, FDA said in a warning letter posted on Tuesday.
FDA inspected plants of Novartis' Sandoz unit in Broomfield, Colorado; Wilson, North Carolina; and Quebec earlier this summer.
The three violations found at the Quebec facility were repeat observations from a 2009 FDA inspection and included the failure to ensure the drugs were produced according to standard.
For instance, inspectors found crystals in some vials of injectable liquid drugs, even though the same problem was brought to the plant's attention in 2009. FDA did not identify any of the specific drugs.
"We are concerned that your firm lacks process understanding to consistently manufacture" the particular injectable, FDA wrote in the letter dated November 18.
The Wilson and Broomfield plants also failed to ensure that the drugs they manufacture have the strength, quality and purity they should -- both repeat violations.
Several pieces of equipment at the Broomfield facility were "still dirty after cleaning had been completed and verified by a supervisor," FDA said.
Tue Dec 6, 2011 3:14pm EST
(Reuters) - Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses.
U.S. Food and Drug Administration investigators found a lack of proper procedures to ensure the drugs' sterility and correct composition. They also found inadequate cleaning at one of the plants, FDA said in a warning letter posted on Tuesday.
FDA inspected plants of Novartis' Sandoz unit in Broomfield, Colorado; Wilson, North Carolina; and Quebec earlier this summer.
The three violations found at the Quebec facility were repeat observations from a 2009 FDA inspection and included the failure to ensure the drugs were produced according to standard.
For instance, inspectors found crystals in some vials of injectable liquid drugs, even though the same problem was brought to the plant's attention in 2009. FDA did not identify any of the specific drugs.
"We are concerned that your firm lacks process understanding to consistently manufacture" the particular injectable, FDA wrote in the letter dated November 18.
The Wilson and Broomfield plants also failed to ensure that the drugs they manufacture have the strength, quality and purity they should -- both repeat violations.
Several pieces of equipment at the Broomfield facility were "still dirty after cleaning had been completed and verified by a supervisor," FDA said.