On November 23-25, 2011, the Food and Drug Administration posted notice of the following recalls of imported food, drugs, animal health products, biologics, or medical devices:
On November 23, the Food and Drug Administration took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants (ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies) from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act. According to the FDA, this is the first time it has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.
On November 23, 2011, 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 announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) concerning a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The Environmental Protection Agency has announced that it is extending the Most Efficient ENERGY STAR pilot through the 2012 calendar year. While EPA intends to maintain the same basic scope and, to a large degree, the requirements of the 2011 pilot for 2012, EPA is proposing a limited number of modest changes. Comments on the proposed criteria should be submitted to mostefficient@energystar.gov by December 15, 2011. EPA will also host a conference call on November 30 to discuss the proposed criteria with interested parties. EPA's proposed 2012 Most Efficient criteria for clothes washers, refrigerators, and central ACs and heat pumps are available via email by sending a request to documents@brokerpower.com.
On November 22, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On November 21, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
U.S. Customs and Border Protection issued a CSMS message announcing that the Food and Drug Administration's Prior Notice System Interface (PNSI) was down for maintenance on November 19, 2011 between 1:00 AM EST and 12:00 PM EST. During this time, ACS, OASIS, and the link between ACS and OASIS were operational but PNSI was unavailable. Prior Notice could be submitted through the ABI/ACS system.
On November 18, 2011, 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 announced that it is expanding an earlier warning to consumers to include additional frozen oyster products from Korea as they have been linked to norovirus cases in Washington state. Some of the product contained in these additional lots has been identified as breaded frozen shucked oyster products, in addition to the individually quick frozen oyster meat recalled earlier. An additional company in Korea, Daihung Mulsan, Inc. has also been identified as a distributor/exporter of harvested product from the area in question during the period February 23-March 16, 2011. Direct importation of the product was limited to distributors in California, New Jersey and Maryland where state regulatory officials are working to monitor the recall of these products by those distributors.