On May 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 12 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 May 4-10, 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 May 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 7 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 May 6 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On May 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 5 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The Food and Drug Administration issued a new draft guidance providing information for industry on the agency’s authority to order mandatory recalls of food products (here). Since enactment of the Food Safety Modernization Act in 2011, FDA has been able to require the “responsible party” that submitted a food facility’s registration to recall adulterated or misbranded food if that party refuses to conduct a voluntary recall. The questions and answers document includes information on which foods are subject to FDA’s mandatory recall authority; the criteria that must be met before a mandatory recall is ordered; the mandatory recall process; and penalties for noncompliance. FDA has only reported using its mandatory recall authority twice since 2011 (see 1504200014). Comments on the agency's draft guidance are due by July 6 (here).