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Belgium Man Gets 4 Years for Counterfeit, Misbranded Drugs Sales
June 7, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration announces that Manuel Calvelo, a citizen of Belgium, has been sentenced to 48 months in federal prison on charges of operating an Internet pharmacy that sold misbranded and counterfeit drugs as well as controlled substances. From 2005 to 2008, he and another man operated Web sites offering for sale without a prescription misbranded and counterfeit drugs to customers in the U.S. in violation of the Federal Food, Drug and Cosmetic Act.

FDA Has Increased Surveillance of Tomatoes, Lettuce, Etc. from Europe
June 7, 2011 by Marie Rapport|FDA and EPA

In response to the E.coli 0104 outbreak in Europe, the Food and Drug Administration stated on June 6, 2011 that the agency is currently conducting increased surveillance of fresh tomatoes, cucumbers, lettuce and raw salads, as well as sprouts and sprout seeds from areas of concern. To date, FDA believes that this outbreak has not affected the U.S. food supply. The U.S. receives relatively little fresh produce from the EU, particularly at this time of year. Due to the short shelf life of most fresh produce and the availability of growing areas in the U.S. and Central America, the EU is not a significant source of fresh produce for the U.S.

FDA Permitting Norepinephrine Injection Imports only by Sandoz
June 3, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration has issued a letter announcing that Sandoz is coordinating with FDA to increase the availability of the norepinephrine bitartrate injection due to the current critical shortage. FDA states that at this time, no other company except Sandoz is authorized by FDA to import norepinephrine bitartrate injection for distribution. Any sales of imported Norepinephrine from any entity other than Sandoz will be considered in violation of the Federal Food, Drug and Cosmetic Act and may be subject to enforcement action by the FDA.

FDA Issues Precautions to Medical Device Firms due to Japan Earthquake
June 3, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has issued a letter to foreign and domestic medical device and component establishments recommending certain immediate precautions to counter possible effects of the March 2011 Japan earthquake and Tsunami on medical devices and their components intended for market in the U.S.

Revised FDA Import Alerts on June 1
June 2, 2011 by Elizabeth Parker|FDA and EPA

On June 1, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on May 31
June 1, 2011 by Elizabeth Parker|FDA and EPA

On May 31, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on May 27
May 31, 2011 by Elizabeth Parker|FDA and EPA

On May 27, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: