Product Safety News

FDA issues “sharply worded” warning to heart device manufacturer.

In continuing coverage, the New York Times (1/16, B2, Meier, Subscription Publication, 1.68M) reports that the Food and Drug Administration “on Tuesday released a sharply worded warning letter to St. Jude Medical, in which it said it might soon fine or take other actions against the company for failing to address agency concerns” about the manufacturing practices the medical device company uses to produce its Durata defibrillator leads. In the warning letter, “dated Jan. 10, the agency said that St. Jude had failed to address a variety of concerns about the component” that were noted during an audit by FDA inspectors at the company’s heart-rhythm unit in Sylmar, California. In a Jan. 11 SEC filing, St. Jude indicated that it was “giving the highest priority to fully remediating” the FDA’s concerns. But the Times says that wording in the FDA warning letter suggests the agency is running out of “patience with St. Jude.”

FDA suspects jerky treats in companion-animal deaths.

NBC News (1/15, Aleccia) in its “Vitals” blog reported that the US Food and Drug Administration believes that since last summer, about “500 dogs” and one cat “may have died after eating chicken jerky pet treats made in China.” Overall, an updated list of complaint reports filed with the FDA “shows the agency has received 2,674 reports of illness involving 3,243 dogs, including 501 deaths,” as well as illnesses in nine cats, “including one death.” The blog points out that the agency’s updated data follows last week’s “voluntary recalls of several popular brands” of jerky treats that were issued after agriculture officials in New York determined that some of the products contained “unapproved antibiotics.” But so far, the FDA has been unable to confirm whether the treats, and the recent pet illnesses and deaths, are linked. The blog provides a list the jerky treats currently under recall.

CIFA links more E. coli cases to tainted lettuce.

Food Safety News (1/16, Goetz) reports, “Another two cases of E. coli O157: H7 have been linked to lettuce” sold at fast-food restaurants – including “KFC, Taco Bell, Burger King and Pizza Hut”– in Canada, bringing the total number of related illnesses to 28. According to the Canadian Food Inspection Agency, the two new cases “occurred in Ontario.” The CFIA said the cases linked to the outbreak occurred “between late December and early January” and, that at present, the majority of patients have “recovered or are recovering.” Food Safety News notes that a list of the lettuce products under recall, which were “grown in California and distributed by Freshpoint Toronto,” is available on the CFIA website.

        Separately, Food Safety News (1/16, Flynn) says that in “explaining how that lettuce contaminated with E. coli O157: H7 came across the border from the US, CFIA now points to how involvement in the Leafy Green Marketing Agreement (LGMA) is a quick ticket across the international border for California-grown lettuce.” The agency said that because the “115 California leafy green producers submit to a mandatory food safety program, they can check ‘Box 22’ on their Confirmation of Sale’s (COS) document and enter Canada almost without slowing down.” Food Safety News points out the current E. Coli outbreak “marks the second time in two years that California-grown lettuce served in Canadian restaurants has been responsible for a foodborne illness outbreak