On Aug. 20 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 a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions and answers on FDA’s July 9, 2009, final rule requiring shell egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs on the farm and from further growth during storage and transportation, and requiring these producers to maintain records concerning their compliance with the final rule and to register with FDA. The final rule became effective Sept. 8, 2009.
On Aug. 17-19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 16 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 Aug. 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Aug. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Italian cheese manufacturer Ciresa Formaggi, Snc. faces detention without physical examination of its products if it doesn’t correct alleged unsanitary conditions at its plant, said the Food and Drug Administration in a warning letter. In January, FDA inspected the plant and found that Ciresa’s Taleggio cheese was stored on splintered and rough surfaces. The cheese was stored on pieces of cloth, but the edges of the cheese came into direct contact with the surface below. In its response to the investigation, Ciresa said it had placed bigger pieces of cloth underneath, but the FDA said the cloth is porous and still does not allow for adequate cleaning as required by the Current Good Manufacturing Practice (CGMP) regulation for food.
The Food and Drug Administration announced the availability of a draft guidance entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” as provided by Section 102 of the Food Safety Modernization Act (FSMA). FSMA amended Section 415 of the Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.
On Aug. 14 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 warned three tobacco product vendors that they face civil penalties and/or refusal of their products at the border if they continue to offer flavored and “modified risk” cigarettes for sale in the U.S. In warning letters sent to Karl Bergman (here) (pennycigarettes.com and saveonfags.com) and Dumitru Chitoroaga (here) (juicynewt.com), both of Moldova, the FDA said the companies sold cigarettes branded as apple, cherry, and mint flavored, which are either adulterated if actually flavored or misbranded if not. Additionally, both companies sold cigarettes described as “light” or “ultra-light” cigarettes, which as “modified risk” tobacco products are prohibited for sale in the U.S. A similar warning letter sent to cigs360.com of Australia (here) also alleged sale of “modified risk” cigarettes in the U.S.