Chiron Gets Warning Letter from the FDA

Chiron Corp. said Friday that it received a warning letter from the Food and Drug Administration asking how the company was investigating contamination that shut down a vaccine manufacturing plant and caused a U.S. flu-shot shortage.

The FDA’s letter also cited observations by its inspectors when they visited the plant in Liverpool, England, in October, Chiron said in a statement. The Emeryville, Calif.-based company didn’t detail those findings.

The FDA did not disclose the contents of the letter. Agency spokeswoman Lenore Gelb said it would be posted on the FDA’s website Tuesday.

Some of the issues the FDA cited in the letter, which requires a response within 15 working days, have been resolved, Chiron said without giving specifics or a date of the notice.

“The warning letter is based on findings from the October inspection and a review of Chiron’s response to those findings,” Chiron spokeswoman Alison Marquiss said. “It is not the result of any newly identified safety issues or findings by the FDA.”

Under FDA policy, such a letter is routinely sent when inspectors conclude that official action is required to correct problems, an FDA official explained Friday. FDA inspections also may rule that no action is required, or they may encourage voluntary improvements. A letter that demands official action is considered more serious.

British regulators Oct. 8 suspended Chiron’s license to make flu shots at the plant after some lots of the Fluvirin vaccine were discovered to be contaminated with bacteria called serratia marascens. The germ can cause infection of the lungs, urinary tract and other tissues.

The suspension, which effectively shut down the plant, cut off 48 million shots, or about half the supply that U.S. health officials were counting on for the current season.

On Tuesday, British health authorities said they were extending the suspension by three months to the end of March, adding to concerns about a possible U.S. shortage next season.

The company has said it needs to begin production at the plant by March in order to deliver vaccine for next season.

“We aim to achieve full remediation in time for the 2005-2006 flu season,” Marquiss said. “We are committing significant resources and expertise to this matter.”

Shares of Chiron rose 25 cents to $31.29 on Nasdaq.

*

Times staff writer Jonathan Peterson in Washington contributed to this report.