April 27, 2010 / 8:49 PM / 9 years ago

UPDATE 1-US FDA warns Teva on California plant problems

* December letter cites problems with sedative production

* Teva says working with the FDA

* Shares fall 2 pct

WASHINGTON, April 27 (Reuters) - U.S. regulators have warned Teva Pharmaceutical Industries (TEVA.TA)TEVA.O about manufacturing violations at a California plant, according to a letter released on Tuesday.

The Food and Drug Administration said a July 2009 inspection found problems with the manufacture of the sedative propofol at a Teva plant in Irvine, California.

The company failed, for example, to test each lot of raw materials used to make propofol for certain toxins, the FDA said in a December 2009 letter to Teva Parenteral Medicines Inc.

The FDA said Teva’s previous responses were inadequate.

Teva spokeswoman Denise Bradley said on Tuesday the company was working with the FDA to address the concerns. Teva has rescheduled a yearly plant shutdown from December to the last week in April “in order to more efficiently address process enhancements at the facility,” she said.

The FDA sends dozens of warning letters per year. Most are addressed without further action, but the agency can seek tougher penalties such as product seizures or injunctions.

Teva shares fell 2 percent to close at $59.70 on Nasdaq.

The FDA posted the letter to Teva here

Reporting by Susan Heavey and Lisa Richwine; Editing by Richard Chang

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