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:
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:
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 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.
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.
On Jan. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 8 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. 31-Jan. 6, 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 Jan. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: