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U.S. inspects CSL, cautions over flu plant problems

WASHINGTON (Reuters) - U.S. health regulators have cautioned Australia's CSL Ltd after uncovering problems at its influenza vaccine manufacturing plant and want to meet with company officials, according to a letter released on Monday.

The U.S. Food and Drug Administration inspected the company's CSL Biotherapies unit, that makes Afluria and H1N1 monovalent vaccines, and found it was not following some of the agency's good manufacturing guidelines.

The agency also called on senior CSL managers to meet with FDA officials, something the agency does not often ask for in such letters.

While a setback for CSL, the findings are unlikely to severely affect the U.S. flu vaccine supply. The FDA did not ask the company to halt production at the Australia-based manufacturing plant, and four other drugmakers are approved to sell such products in the United States.

Merck & Co Inc has exclusive rights to sell and distribute Afluria seasonal flu vaccine in the United States starting with the 2010-2011 flu season under a 6-year deal.

Other major influenza vaccine makers that supply the United States are Sanofi Aventis SA, Novartis AG, AstraZeneca and GlaxoSmithKline.

According to the letter, CSL's unit "failed to thoroughly investigate any unexplained discrepancy" or batch failures. It also failed to establish testing procedures designed to assure components conform to "appropriate standards of identity strength, quality, and purity," the letter said.

The letter, posted to the FDA's website at http://link.reuters.com/wub64m , follows an April 2010 inspection of the company's Melbourne, Victoria facility, but it was unclear when the agency sent the letter to CSL.

A CSL Biotherapies spokeswoman could not immediately be reached for a comment.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

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