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.
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.
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:
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.
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:
The Food and Drug Administration warned a device manufacturing facility in the Czech Republic that its products may be subject to import refusal and detention without physical examination, because of violations of Medical Device Reporting and current good manufacturing practices regulations. The warning letter, dated Dec. 12, said Biotronik Fortress Introducer Sheath System devices, manufactured by Contract Medical International, are misbranded and adulterated. Although the company has responded to FDA’s findings, it did not include adequate supporting documentation.
The Food and Drug Administration said three seafood processors in Canada and China have inadequate seafood Hazard Analysis and Critical Control Point (HACCP) plans, and may refuse admission of their products, in warning letters posted to the FDA website Dec. 25. Seapak (here) and Ocean Pier (here) of Canada, as well as Koon Cheong Lung (here) of China, were sent the letters. Because the alleged violations are materially related to food safety, the FDA may also assess reinspection fees, it said, so all three seafood processors should inform their U.S. Agents.
On Dec. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: