The Food and Drug Administration posted translations of its fact sheets on revisions to several proposed rules under the Food Safety Modernization Act. Now available are translations into Spanish, Simplified Chinese, Traditional Chinese, and Japanese of summaries on its Sept. 29 supplemental proposals on produce safety (here), preventative controls for human food (here), preventative controls for animal food (here), and the Foreign Supplier Verification Program (here) (see 14092901). FDA also recently posted annotated “redline” side-by-side comparisons of each original and revised proposed rule.
On Oct. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 2 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 Oct. 1 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Oct. 1, 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 recently warned an Indian drug company that it may block admission of its products at the border for failure to pay generic drug user fees. In a warning letter dated Aug. 28, FDA notified Marck Biosciences Limited that it failed to pay fees for 2013 and 2014 required by the Generic Drug User Fee Amendments of 2012 for a facility in Gujarat. The facility has been placed on the GDUFA arrears list (here), and drugs manufactured at the facility may be refused admission to the U.S. as a result, said FDA.
The Food and Drug Administration announced a new online Data Dashboard with information on agency inspections, warning letters, seizures and injunctions, and recall statistics. The tool allows users to view summary reports and trends, as well as country- and area-specific inspection data. FDA plans to update the data semi-annually, it said (here).
During the week of Sept. 22-28, 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 Sept. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: