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.
On Feb. 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’s Cincinnati District, in conjunction with Xavier University, will hold the “PharmaLink 2013” conference on the global pharmaceutical supply chain March 12-14 in Cincinnati. Topics on the agenda include the impact of new legislation on the global supply chain, FDA policy and guidance, and the impact of contract manufacturing on drug shortages. Advance registration ends Feb. 18, but registration will be available after that date and onsite at increased rates. Registration and the conference agenda are available here.
On Feb. 6 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. 6 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 the February Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration scheduled meetings to discuss its recently proposed produce safety and preventative controls rules in Chicago on March 11-12, and in Portland, Ore., March 27-28. FDA will also ask for comments from stakeholders on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules, it said. FDA already announced a similar meeting in Washington, D.C. Feb. 28 -- March 1.
The Food and Drug Administration posted a Dec. 12 warning letter it sent to Novo Nordisk, after finding violations of current good manufacturing practice regulations for the company’s drug products at its Bagsvaerd, Denmark, facility. FDA said it may withhold approval of new applications of supplement listings for the company, and could even deny admission to Novo Nordisk’s drugs manufactured at the offending facility. Novo Nordisk had 15 working days to respond to the letter, which have already elapsed.
On Feb. 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 sent warning letters to three device manufacturers in Germany, Switzerland, and Korea, detailing violations of current good manufacturing practice regulations by each facility. FSSB Chirurgische Nadeln of Germany (here), and Tecval Medical of Switzerland (here), were each warned by FDA that premarket approval applications and requests for certificate to foreign governments may be denied until their violations are corrected. Given the “serious nature” of violations by Sometech Incorporated of Korea (here), FDA will keep that company’s products on import alert, it said.