US FDA cites violations at three Novartis plants
Inspections held during 2011 found significant violations of cGMP regulations
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 to the Swiss pharmaceutical manufacturer’s chief executive, Joe Jimenez, 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.
The Broomfield and Wilson facilities were criticised for not having adequate written procedures for production and process controls to ensure medicine quality. They were also criticised for failing to ensure that the drugs they manufacture have the strength, quality and purity they should – both were repeat violations.
The FDA additionally found several pieces of equipment at Broomfield that were still dirty after cleaning had been completed and verified by a supervisor.
The three violations at the Bourcherville plant were repeat observations from a 2009 FDA inspection and included the failure to ensure the drugs were produced according to standard.
For example, inspectors found crystals in some vials of injectable liquid drugs, even though the same problem was brought to the plant's attention in 2009. The FDA did not identify any of the specific drugs.
The FDA said Sandoz Canada must develop and implement an SOP and appropriate training of all relevant employees detailing the process and responsibilities for handling Field Alert Reports. The FDA will verify the implementation and effectiveness of this corrective action during a future inspection of the Boucherville facility.