The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:
The U.S. Food and Drug Administration is warning consumers not to eat frozen mamey fruit pulp sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif., or the Goya brand by Goya Foods Inc. Secaucus, N.J. as a link has been found between the pulp and an ongoing outbreak of Salmonella Typhi infections. Both the Goya and La Nuestra products are sold frozen. All production lot codes are being recalled. The UPC is 041331090803 for the Goya product and 7-56869-10008-4 for the La Nuestra Product. Mamey fruit (sometime referred to as "zapote") is large and round, has brown skin and a fleshy orange pulp. It is grown mainly in the tropical lowlands of Central America and is very popular among the Hispanic community, especially in juices and fruit shakes (called "batidos").
The Food and Drug Administration is announcing a public workshop on September 23, 2010, entitled "Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations," to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. Comments are due by October 22, 2010.
The Food and Drug Administration is announcing a public conference on September 13-15, 2010, entitled "The New Paradigm: Quality and Compliance in Merging and Emerging Cultures," which will focus on challenges facing the medical products industry in navigating regulatory compliance, achieving worldwide quality improvement, and enhancing quality system controls in an environment of merging and emerging cultures.
The Consumer Product Safety Commission is seeking comments on the following information collection for which they have requested or intend to request Office of Management and Budget approval or extension of approval (see notices for specific details):
The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:
The Consumer Product Safety Commission has published notice of the following voluntary recalls:
The Consumer Product Safety Commission has issued a final rule making corrections to certain warning and test provisions of its June 2010 final rule establishing a mandatory safety standard for infant walkers.
The Consumer Product Safety Commission has published notice of the following voluntary recall:
The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of: