December 23, 2008 / 4:56 PM / in 11 years

UPDATE 1-U.S. FDA warns Haemonetics over quality control

(Adds details from FDA letter)

WASHINGTON, Dec 23 (Reuters) - Haemonetics Corp (HAE.N) has failed to correct a variety of manufacturing issues, including taking proper steps to ensure the quality of its blood collection products, the U.S. Food and Drug Administration warned in a letter released on Tuesday.

The company, which makes devices and other products to collect and process blood, must have an outside expert consultant audit its manufacturing and quality systems, the FDA also said in its letter dated Dec. 4.

After the letter’s release, shares of Haemonetics were off 3 percent, or $1.70, at $54.07 in late morning trade on the New York Stock Exchange.

FDA officials uncovered the problems while inspecting the company’s Niles, Illinois, plant in June and July. Haemonetic responded to the investigators’ concerns in late July, but the FDA found many of its steps were inadequate.

Among the violations were Haemonetics’ failure to set up quality control procedures for suppliers and contractors. It also did not properly set up systems to verify product standards, the letter said.

Representatives for the company did not immediately return a request for comment.

Haemonetics has 15 days to respond to the FDA’s warning letter. The agency can take a variety of punitive actions, including levying fines or seeking an injunction, although most similar cases are resolved without further action.

The FDA posted the letter on its website here

Reporting by Susan Heavey, editing by Dave Zimmerman

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