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:
During the week of Dec. 17-23, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Dec. 19-20 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 will now accept electronic versions of private laboratory reports, said CBP in a CSMS message. Electronic submission is preferred, though the FDA will still accept hard copies. The FDA intends to automate its analytical reports review processes, said the CSMS message. Once that's accomplished, FDA will be able to process private laboratory analytical reports submitted via electronic means in less time than is needed to process private laboratory analytical reports submitted in hard copy forms, it said. To avoid potential delays, private laboratory analytical reports should be submitted electronically, said CBP.