ORLANDO, Fla. – The upcoming Food and Drug Administration pilot to test filing and release of FDA-regulated entries in the Automated Commercial Environment will start with drugs before expanding to other products, said Domenic Veneziano, FDA director of import operations, at the annual conference of the National Customs Brokers & Forwarders Association of America April 22. The pilot, which will begin July 1, will start at three ports: Baltimore, Otay Mesa and Philadelphia, he said. The agency wants to make sure its IT systems are running smoothly before adding other FDA-regulated products to the pilot, but intends to eventually test all types of commodities before ACE cargo release becomes mandatory in November, said Veneziano. Medical devices will come after drugs in August, he said. Veneziano announced the FDA pilot would begin in July at a webinar last March (see 1503240065).
On April 21 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 13-19, 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 April 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 17 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 released a report submitted to Congress in February on the agency’s use of Food Safety Modernization Act mandatory recall authority (here). FDA is required by FSMA to report every two years on its mandatory recall authority, which allows FDA to order the recall of dangerous food if the distributor does not voluntarily cease distribution. FDA again reported only one use of its mandatory recall authority in 2013 and 2014, threatening to order a recall unless supplement maker USPlabs recalled supplements that were suspected to have caused an outbreak of hepatitis in Hawaii. USPlabs carried out a voluntary recall as a result. FDA also reported using its mandatory recall authority only once in its first report to Congress covering 2011 and 2012 (see 14012925).
The Food and Drug Administration issued its weekly Enforcement Report for April 15 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 April 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 14 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 6-12, 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: