The Food and Drug Administration issued its weekly Enforcement Report for Feb. 13 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
Food and Drug Administration Commissioner Margaret Hamburg lauded a new Institute of Medicine report on “Countering the Problem of Falsified and Substandard Drugs” for its “thorough discussion and recommendations.” IOM’s report identifies causes and public health consequences of substandard and falsified drugs and recommends strategies to address the problem.
The Food and Drug Administration is extending until May 16 the period for submission of comments related to information collection provisions of its proposed rules on produce safety and preventative controls. The two proposed food safety rules, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published Jan. 16, apply to both foreign and domestic producers. The 90-day extension of the period for comments on proposed information collection requirements means the deadline for all comments, whether related to provisions of the proposed rules or the information collections, falls on the same date.
ZIP International Group of New York is recalling dry salted fish because the product was found to be uneviscerated and may be contaminated with Clostridium botulinum. The recalled product, dry salted fish (bream) imported from Russia, was distributed by East Coast Foods, also of New York, to retail stores and wholesalers in September 2012. It is packaged in sealed packaging labeled "Astrakhansky Lesh" (Dry Salted Fish Eviscerated) weight 14.2oz. Bar Code 835856001228 is located on the top right corner of the package.
On Feb. 13 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 sent a warning letter to P.A. Benjamin Manufacturing, a drug company based in Jamaica, detailing violations of current good manufacturing practice regulations, as well as unapproved new drug and misbranding violations. Specific problems included labeling violations and use of active ingredients that do not comply with requirements for cold and cough medicines for over-the-counter use. FDA said it may continue to refuse admission of drugs manufactured at P.A. Benjamin’s Kingston facility as a result.
During the week of Feb. 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:
The Food and Drug Administration posted an online training module for foreign aquaculture producers to help them comply with FDA seafood import regulations. The module is hosted by the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland, which also provides certificates upon completion. The training course is designed to clarify how FDA regulates drugs for aquaculture, and provides information to help identify what drugs may be used and how they should be used to prevent unacceptable residues. The course also includes a section on the judicious use of antimicrobials. The module is available here.
On Feb. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
DZH Import & Export Inc. of New York is recalling its “Curiosity Of Dashan” dried mushrooms imported from China because of undeclared sulfites that could provoke allergic reactions. The recalled mushrooms come in a 3.5oz containers, packed on a plastic tray with the following code: BEST BEFORE: MAY 3rd, 2013. The UPC code is 6939457003484. The product was sold in New York City.