The Food and Drug Administration issued its weekly Enforcement Report for Feb. 27 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued its international food safety capacity-building plan, as required by the Food Safety Modernization Act. FSMA requires FDA to develop a plan to expand technical, scientific, and regulatory food safety capacity of foreign governments and food industries in countries that export food to the U.S.
On Feb. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 26 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 will continue to target imported cantaloupes at the border for sampling after two major outbreaks in recent years, it said in a letter to the cantaloupe industry. The letter encouraged the cantaloupe industry to “observe best practices already recognized by FDA and the industry as effective in reducing the risk of harmful contamination,” it said. The outbreaks occurred in 2011 and 2012 as a result of unsanitary conditions at domestic cantaloupe packinghouses, FDA said, and were caused by the bacterial pathogens listeria monocytogenes and salmonella.
On Feb. 25 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 is debarring Richard Stowell from importing food or offering food for importation into the U.S. in connection with his conviction for mislabeling shrimp imports. Stowell, who was president of Florida-based seafood wholesaler United Seafood Imports, pleaded guilty in 2011 to one count of conspiracy to falsely label and misbrand seafood, one count of false labeling of seafood under the Lacey Act, and one count of misbranding food.
On Feb. 22 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 Feb. 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration said a guidance is now available on industry implementation of Physician Labeling Rule content and format requirements in labeling for human drug and biological products. FDA said the guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the physician labeling requirements. The Physician Labeling Rule, published in 2006, addresses prescription drug labeling that is used by prescribers and other health care practitioners. Comments on the guidance may be submitted at any time, FDA said. The guidance is available here.