The Food and Drug Administration issued its weekly Enforcement Report for May 2, 2012, that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
During the week of April 24 through April 30, 2012, the Food and Drug Administration modified the following existing Import Alerts on the detention without physical examination of:
On May 2, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 1, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 30, 2012, 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 announced that the 15th Annual Education Conference, cosponsored with the Orange Country Regulatory Affairs Discussion Group (OCRA), will be in Irvine, CA, June 6-7, 2012. The conference is intended to give the drug, device, biologics, and dietary supplement industries an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The FDA said the main focus of the Conference will be product approval, compliance, and risk management in the three medical product areas.
The Food and Drug Administration recently announced the availability of the following guidance and draft guidances:
On April 27, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 26, 2012, 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 announced that Café-Tasse S.A. is voluntarily recalling its 1.58 oz. Café-Tasse Noir (Dark) Belgian chocolate bar with best before date of “15 SEPT 2013” because it may contain undeclared traces of milk. No illnesses have been reported to date.