As Teva grows, quality challenges arise

Generics-maker Teva, like other big pharma companies that have grown via acquisitions, faces a challenge as it continues to grow: maintaining quality control. The company recently ran afoul of GMP standards and was cited for "serious violations" in a warning letter concerning an intravenous drug plant in Irvine.

FDA inspectors raised concerns about bacterial contamination in the generic propofol manufactured at the Irvine plant. Teva recalled thousands of vials of the anesthetic and shut the plant temporarily while it assessed the manufacturing quality situation.

And as reported earlier this week, Teva is facing another propofol challenge: a Nevada jury just assessed it, and distributor Baxter, $500 million in fines for infecting patients. The fines stem from a 2008 hepatitis C outbreak, which followed reuse of syringes and vials of the anesthetic by endoscopy clinics. Teva says there are "numerous grounds for appeal" and will contest the verdict.

The company maintains in a New York Times article that quality missteps are rare for it. The FDA's warning letter archive substantiates that claim. "When you are producing 60 billion tablets a year in 38 different locations in the world," says Teva CEO Shlomo Yanai, in the article, "you have to be very aware that quality is the number 1 priority."

- here's the NYT article
- see the warning letter