The Food and Drug Administration threatened to refuse entry of German drug manufacturer Hameln Pharmaceuticals’ drug products for current good manufacturing practice regulation violations, it said in a warning letter (here). The refusal would only apply to the company’s Hameln, Germany facility, the agency said. FDA may also withhold approval of new applications or supplements listing Hameln Pharmaceuticals as manufacturer if the violations aren’t corrected.
The Food and Drug Administration may refuse imports from device manufacturers from the U.K., Korea, and Israel for current good manufacturing practice requirement violations, it said in several warning letters. Central Surgical of the UK (here), Interojo of Korea (here), and Curatonic of Israel (here) were named in the letters. FDA also took Curatonic to task for unapproved marketing of its devices. Richway of Korea (here) was also sent a warning letter for CGMP violations, but FDA stopped short of threatening refusal of its imports.
The Food and Drug Administration may refuse entry of fish products from two Canadian processors for violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations, it said in two recently published warning letters. North Fish’s HACCP plans are inadequate for salted herring, dried salted white fish, and refrigerated cold smoked mackerel, rendering those products adulterated, FDA said (here). Fisherman's Market’s mackerel, mahi mahi, marlin, herring, shad, tuna, and vacuum packaged frozen cooked lobster, crab and shrimp products are adulterated for the same reason, it said (here).
On Jan. 14 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 Jan. 7-13, 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:
The Food and Drug Administration (FDA) issued the January Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Jan. 11 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 Jan. 9 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 may refuse entry of Taiwan Three Mast Pharmaceutical’s drug products for violations of Current Good Manufacturing Practice regulations, it said in a warning letter. Three Mast is also engaging in unapproved marketing of one of its products, FDA said, by marketing its Imbue Pain Relief Patch as an external analgesic for treatment of tendonitis and bursitis, which are not approved uses.
The Food and Drug Administration posted three fact sheets and a presentation on its proposed produce safety regulation for facilities that grow, harvest, package and hold raw produce, as well as its Hazard Analysis and Risk-Based Preventative Controls (HARPC) regulation for facilities that manufacture, process, pack or hold human food. Importers will be responsible for verifying their foreign suppliers’ compliance with these regulations per the Foreign Supplier Verification Program. The produce safety regulation fact sheet is available here, and a fact sheet on the regulation’s subparts is available here. The HARPC fact sheet is available here. Presentations on the two regulations, as well as other provisions of the Food Safety Modernization Act, are available here.