Novartis Stops Parts of Production at Yet Another Manufacturing Plant

Novartis Stops Parts of Production at Yet Another Manufacturing Plant

February 21st, 2012 // 1:29 pm @

Source: Pharmalot

For the second time in less than three months, Novartis has been forced to halt production of medicines at one of its plants after recent FDA inspections found various manufacturing problems. This time, its Sandoz unit has suspended or discontinued production of some medicines at a facility in Boucherville, Quebec. In December, all production was suspended at a plant in Lincoln, Nebraska.

In letters written to customers late last week, Sandoz described the action as temporary, although it remains unclear when production will resume. Production of oral products, patches and the Omnitrope growth hormone will not be affected. Instead, production of ointments, ophthalmics, suppository dosage forms and injectables for illnesses that are not life-threatening ill be curtailed, according to Michel Robidoux, the president and general manager of Sandoz Canada (read the letter).

“Our objective is to restore normal levels of supply as soon as possible…,” according to a different letter from Gordon Meyer, vp of the Sandoz Canada hospital division, and Jacquelin Gagnon, vp of the Sandoz Canada retail division. “At present, we have focused all available capacity on the supply of life-saving and acute injectable care medicines to ensure that patients with critical medical conditions continue receiving adequate treatment.”

The drugmaker has been repeatedly scrutinized by the FDA over the past year as part of an agency effort to heighten its oversight of manufacturing facilities in the wake of the Heparin scandal. Since then, the FDA has attempted to get tougher with drugmakers and their ingredients suppliers, and Novartis has become a prime example. Following inspections at three Sandoz plants, the FDA last November issued warning letters to Novartis ceo Joe Jimenez (see this).

Meanwhile, the FDA found a boatload of embarassing problems at the Novartis plant in Nebraska, which makes over-the-counter items such as Excedrin, Theraflu, Triaminic, Maalox and Lamisil, as well as Animal Health meds and also does contract manufacturing work for other prescription drugmakers, such as Endo Pharmaceuticals.

One big problem: Novartis failed to investigate consumer complaints about mixed-up tablets in bottles, among other serious violations (read more here). There were also failures to to train employees in quality systems, extend investigations of known problems to all products affected; assure processes remain in a current validated state and have an adequate number of trained staff in the quality unit.

The FDA issued a pair of 483 inspection reports (which you can read here and here), and the drugmaker has recalled OTC and Animal Health meds and is estimated to lose hundreds of millions of dollars in sales (see here, here and here).

The agency has also visited a Novartis plant in Suffern, New York, according to sources who say the drugmaker recently retained the Quantic Group to assist with quality control upgrades. This is the same consulting firm that helped Genzyme, the Sanofi unit, after a consent decree was signed with the FDA. A Novartis spokesman described the assistance as “routine” and “not reflective of quality control issues nor should it be taken as an indication that a problem exists.”

Separately, the drugmaker experienced problems with the water system at this plant. A Novartis spokeswoman acknowledged that, last month, there was an “accidental discharge of propylene glycol into the facility’s domestic water system” and the material is “is considered non-toxic.” She added the system was flushed out to remove propylene glycol and will be tested and monitored. “There is no impact to any products produced at the Suffern facility and there is no risk to the surrounding community… Local government officials were notified.”


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