On April 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 15 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 April 8-14, 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 is proposing to establish minimum and maximum levels of selenium in infant formula. The proposed rule would also add selenium to the statement of amounts of nutrients for infant formula labeling, to be listed between iodine and sodium. Comments on the proposed rule are due by July 1, except for comments on proposed information collection requirements, which are due by May 16.
The Food and Drug Administration will begin its month-long reporting period for generic drug facility self-identification for fiscal year 2014 on May 1. Between May 1 and June 1, generic drug facilities, certain sites, and organizations identified in a generic drug submission are required to submit, update, or reconfirm identification information to FDA, it said. More information, including generic drug facilities that have to register, is available (here).
On April 12-14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 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 April 10 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On April 10 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 to refuse imports from Guatemalan and Costa Rican produce farms and packing houses after finding “objectionable conditions and practices” at each, according to two agency warning letters.