Layoffs are coming at a Teva Pharmaceutical Industries plant that's been on hold since last April. As in-Pharma Technologist reports, Teva will axe 200 jobs at the facility, which was idled after FDA inspectors found manufacturing violations there. The cuts come on top of 70 Teva jobs lost last year after the company stopped making the anesthetic drug propofol.
The Irvine, California, plant had been making propofol in 2009 when Teva recalled more than 57,000 bottles after 41 patients reported flu-like symptoms. Some of the recalled vials were contaminated with bacterial endotoxin. An FDA warning letter later prompted Teva to suspend production last April. FDA cited Teva for failing to test for endotoxin in all lots of raw materials used to make propofol. The agency also faulted plant officials for their inability to determine why excessive endotoxin was found in three propofol vials.
Until now, the company hasn't cut loose any employees because of the production halt in Irvine, Teva spokeswoman Denise Bradley told in-Pharma. "The jobs which are being eliminated are all various production jobs and support staff at the facility," she said. The company still intends to resume production at the plant, but she couldn't offer a timeframe for that.
Teva's idled plant is just one of several drug-making facilities now on hold for quality-control reasons. After a high-profile consumer drug recall, Johnson & Johnson temporarily suspended production at its Fort Washington, Pennsylvania, plant to allow for a revamp. And Ranbaxy Laboratories still cannot import meds made at a factory in India; the FDA has had those products on hold for more than a year.
- see the in-Pharma piece