The Food and Drug Administration issued its weekly Enforcement Report for Dec. 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Dec. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 26 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 is asking for comments by Jan. 27 on its collection of information from import entry documentation. In addition to reviewing information provided to CBP through the Automated Commercial System, FDA also requires importers to declare the FDA Product Code, FDA country of production, manufacturer/shipper, and ultimate consignee, before the agency makes its admissibility decision. FDA says 3,406 respondents report that information each year for non-tobacco shipments, providing 1,089 responses each that take 8 minutes each to compile, for a total of 517,219 burden hours each year.
The Food and Drug Administration is finalizing amendments to its food additive regulations to implement food-grade specifications from the 7th Edition of the Food Chemical Codex. The final rule makes changes regulations on 32 food additives, taking effect on Nov. 29. Objections and requests for hearings are due by Dec. 30.
The Food and Drug Administration physically examined 1.9 percent of food and feed import lines in fiscal year 2012, said the agency in its 2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. That’s down from 2.3 percent in FY 2011, and 2.1 percent in FY 2010, according to past versions of the report, which is required by the Food Safety Modernization Act. The total number of physically examined food and feed import lines, including through field exams and sampling, stood at 207,839 in FY 2012, well down from a total of 243,400 in FY 2011 and only slightly higher than the FY 2010 total of 206,723, even as the total number of food import lines rose from 9,974,948 in FY 2010 to 11,136,599 in FY 2012. According to FDA, the average cost of physical inspection is about $160 per field exam and about $3,100 per sample analyzed.