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.
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.
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. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination 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.
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 19 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. 18 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 threatened device importer and distributor Prime Herbs Corp. with seizure, injunction, and civil monetary penalties for a host of violations that caused FDA to declare the company’s infrared heating lamp adulterated and misbranded. The warning letter, dated Dec. 10, alleges violations of current good manufacturing practice regulations, Medical Device Reporting violations, unapproved marketing, and failure to provide adequate directions for use. FDA said the violations could also affect the awarding of government contracts, as well as premarket approval for related products.
On Dec. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: