Do More With Reuters
Partner Services

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

Tue Dec 23, 2008 10:25pm IST
 
Email | Print | | Single Page
[-] Text [+]

(Adds details from FDA letter)

WASHINGTON, Dec 23 (Reuters) - Haemonetics Corp (HAE.N: Quote, Profile, Research) 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)

Dubai Debt Fears

Villas are seen on the The Palm, Jumeirah, with Atlantis, The Palm, under construction on the breakwater (crescent), May 3, 2008.  REUTERS/Jumana El Heloueh

Banks outside the Gulf played down their exposure to Dubai debt, after fears the emirate could default and even derail world economic recovery prompted a sell-off in global markets.  Full Article | Slideshow 

India Investment Summit 2009
India Investment Summit 2009

Top executives and bankers discuss their own plans and the broader opportunities and challenges for India.  Full Coverage 

People stroll outside the Taj Mahal hotel ahead of the first anniversary of the militant attacks in Mumbai, November 24, 2009.  REUTERS/Punit Paranjpe
Investors worry about another attack

The risk of militants striking again worries investors who fear that a second attack similar to last year's Mumbai raids could shake the economy.  Full Article | Full Coverage 

Market Update

  • IndiaIndia
  • USUS
  • UKUK
  • Asia
  • Most Actives

road to Copenhagen

BLOGS

Photo
Calculated Move

Reliance aims big with $12 bln bid for LyondellBasell.  Blog 

SHOWCASE

Capital Raising
Capital Raising

Analysis - China banks' rush for billions could trip markets.  Full Article 

 
Photo
Bonus Payout

"Bonus" has become a dirty word on Wall Street.  Full Article 

 
Bubble trouble?
Bubble trouble?

With the BSE Sensex at around 17,000 points, are the Indian equity markets looking at a possible bubble?   Commentary 

 
Funding Blues
Funding Blues

A popular tactic used by Indian brokerages to raise money for rich clients is likely to be banned.  Full Article 

 
Recovery Path
Recovery Path

Indian techie logging out of downturn gloom.  Full Article 

 
Central Banks Cautious
Central Banks Cautious

Reuters tracks the policies of the world's top central banks as the debate over global economic recovery rages on.   Full Coverage 

 
Risky Proposal
Risky Proposal

Rupert Murdoch courts trouble if he blocks Google on news.  Full Article