FDA Warns Haemonetics Over Blood Collection Products

The U.S. Food and Drug Administration issued a warning letter Dec. 4 to Haemonetics Corp., saying it failed to fix several manufacturing issues, including taking proper steps to ensure the quality of its blood collection products.

The Braintree, Mass.-based company, which manufactures devices and other products to collect and process blood, must have an outside expert audit its manufacturing and quality systems, the FDA said.

 FDA officials discovered the problems while inspecting the company’s Niles, Ill., plant in June and July. Haemonetic responded to the investigators’ concerns in late July, but the FDA found many of its steps to be unsatisfactory.

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

Company representatives did not return requests for comment. 

Go to http://www.fda.gov/foi/warning_letters/s7060c.htm to view the warning letter.