The Food and Drug Administration proposed its produce safety rule Jan. 4, alongside its proposed rule on Hazard Analysis and Risk-Based Preventative Controls. The produce safety rule would apply to farms that grow, harvest, pack, or hold covered produce, including foreign farms that export to the U.S., with certain exceptions. Under the upcoming Foreign Supplier Verification Program, imports will have to verify their foreign suppliers’ compliance with either produce safety regulations or HARPC requirements, depending on the product being imported. The proposed produce safety rule is currently on public inspection, and is set for publication in the Jan. 16 Federal Register. See a future issue of International Trade Today for details.
The Food and Drug Administration issued its weekly Enforcement Report for Jan. 2 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued its proposed rule on Hazard Analysis and Risk-Based Preventative Controls (HARPC). The proposal is currently on public inspection, and is set for publication in the Jan. 16 Federal Register. Pursuant to the Food Safety Modernization Act’s requirement that FDA establish a Foreign Supplier Verification Program, importers will have to verify their suppliers’ compliance with HARPC, among other food safety regulations, with some exceptions. “A proposed rule on foreign supplier verification is closely interconnected to this rule on preventive controls for human food, and is expected to publish soon,” said FDA in its HARPC proposal. See future issues of International Trade Today for details.
On Jan. 3 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 sent warning letters to five foreign device manufacturers in Europe and Asia, detailing various violations of current good manufacturing practices and Medical Device Reporting regulations. The warned companies include TMS International (here) of the Netherlands; Energist Limited of the U.K. (here); Meridian AG of Switzerland (here); Hangzhou Jinlin Medical Appliances of China (here); and Tianjin Hanaco Xingda Medical of China (here). Energist was also ordered to cease and desist marketing in the U.S. of its “Ultra Plus VPL for ‘skin rejuvenation’” because it is allegedly being marketed for unapproved uses.
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 26 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. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Chilean food processor Procesadora de Productos Marinos Delifish S.A. is voluntarily recalling its cold-smoked salmon products, said the Food and Drug Administration. The salmon, imported from Chile and distributed in 11 U.S. states and Puerto Rico, is potentially contaminated with Listeria. No complaints or illnesses had been reported as of Dec. 28. No other products supplied by Delifish or Marine Harvest USA are involved in this case, FDA said.
On Dec. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: