FDA cites Teva for 'significant' manufacturing violations

The FDA's manufacturing police has another company on the hook: Teva Pharmaceutical Industries (NASDAQ: TEVA). In the latest of a string of manufacturing-related warnings, the agency cited Teva for "significant" manufacturing violations at a California facility that makes the injectable sedative propofol.

According to the Dec. 11 warning letter posted by the FDA yesterday, inspectors found that Teva had not screened every lot of raw materials for bacterial endotoxins. The company did find abnormal levels of endotoxin in three vials of the drug, but it couldn't figure out how the drug was contaminated; that lot of propofol was later recalled.

The FDA says Teva hasn't done enough to correct the manufacturing violations, and it demands that the company come up with a plan to do so. Teva spokeswoman Denise Bradley told Reuters that the company is working with the FDA to address its concerns. It plans to shut down the plant this week "in order to more efficiently address process enhancements," Bradley told the news service.

Teva's manufacturing problems have helped touch off a shortage of propofol, the Wall Street Journal notes. To help ease the problem, the FDA has allowed APP Pharmaceuticals to import a similar med, Propoven, into the U.S. That drug isn't FDA-approved, but it is licensed for use in other countries.

- see the FDA warning letter
- get the news from Reuters
- read the WSJ article (sub. req.)

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