The Food and Drug Administration issued a warning letter to Italian company BTS S.p.A., which said the FreeEMG and PocketEMG medical devices manufactured by that firm are adulterated because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation. FDA said that, although it previously received a response from the company concerning its investigation, the response was not adequate. According to FDA, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved, and Requests for Certificates to Foreign Governments will not be granted, until the violations have been corrected.

The Food and Drug Administration found serious deviations from the acidified food regulations during an inspection of the Zory, Poland facility of Polish Company Smak Sp. z o.o., FDA said in a warning letter issued May 15. According to the warning letter, Smak intentionally made changes to the thermal processing method of its acidified food products and failed to submit revised scheduled process filings to FDA before manufacturing and shipping such acidified food products as red beets grated, pickled mushrooms, sauerkraut, sauerkraut with carrots, and pickled cucumbers. FDA acknowledged receipt of revised process filings in February 2012, but said that these filings were returned as inadequate as they were missing critical processing information.

Indonesianfoodmart.com of Rockville, MD, is recalling all packages of "Tempeh Starter Yeast" because they have the potential to be contaminated with Salmonella, the Food and Drug Administration said. The recalled "Tempeh Starter Yeast "and “Super Starter Yeast” were distributed nationwide and internationally through direct mail orders. The product was also distributed to the following areas: Australia, Canada, Slovenia, New Zealand, Brunei, Poland and Croatia. The product comes in sealed, clear plastic packages marked with a small computer printed label. The following sizes were sold: 30gm, 50gm, 250 gm, and 1000 gm. Several illnesses have been reported to date that may be in connection with this problem. Upon being notified of the risk by the FDA, the Indonesianfoodmart.com immediately discontinued their operations. Indonesianfoodmart.com did not manufacture the product which was imported from Indonesia.

On May 21, 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 18, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Caribe Produce LTD Co. of McAllen, TX, is recalling 286 cases of Papaya Maradol, Caribeña Brand papayas packed in 35 lb. cartons marked with the brand “Caribeña“ and “Product of Mexico" stamped on the side, said the Food and Drug Administration. The papayas are sold individually, and each one bears a label which states “3112 CARIBEÑA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com.” These papayas have the potential to be contaminated with Salmonella.

River Ranch Fresh Foods, LLC of Salinas, CA recalled retail and food service bagged salads, because they have the potential of being contaminated with Listeria monocytogenes following routine random retail salad finished product tests conducted in the marketplace by the Food and Drug Administration, said the FDA. Retail salad products under this recall were distributed in the U.S. and Canada under various sizes and packaged under the brand names of River Ranch, Farm Stand, Hy-Vee, Marketside, Shurfresh, and The Farmer’s Market. Food service salad products under this recall were distributed in the U.S. and Canada under various sizes and packaged under the brand names of River Ranch, Cross Valley, Fresh n Easy, Promark, and Sysco.

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: