Gills Onions, LLC of Oxnard, CA is initiating a voluntary recall of 2,360 pounds of diced red onions with lot code 51RDA1A2119 and use-by-dates May 14, 15 and 17, 2012, because it may be contaminated by Listeria monocytogenes, said the Food and Drug Administration. The product is beyond its use-by-date, but FDA said no other Gills Onions product is affected by this recall.
The Food and Drug Administration requested comments by July 20, 2012, and announced a public meeting on June 19, 2012 in Washington, DC, on its capacity-building plan, pursuant to the Food Safety and Modernization Act (FSMA), to improve international food safety capacity. FDA said the meeting, entitled “International Capacity Building with Respect to Food Safety,” will open with a discussion of the context for international food safety capacity building and then proceed with more specific discussions about the capacity-building plan.
On May 17, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for May 16, 2012, that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
During the week of May 1 through May 7, 2012, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination of:
On May 14, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 11, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 10, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Food and Drug Administration denied requests for a hearing on its October 2000 final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of microbial pathogens in seeds for sprouting. FDA said that, after reviewing objections to the final rule and requests for a hearing, it has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation.
Compliance dates for the FDA’s final rule for over-the-counter sunscreen drug products is now delayed by six months, i.e. until December 17, 2013 (from June 17, 2013), for products with annual sales of less than $25,000 and December 17, 2012 (from June 18, 2012), for all other products subject to the rule, the Food and Drug Administration announced.