Watch out dictionary lovers and English majors, the U.S. Food and Drug Administration (FDA) is about to make your head spin. In its recent proposed rule for the Hazard Analysis and Risk-Based Preventive Control (HARPC) requirements under FSMA, FDA spent numerous...
A recently published FDA Warning Letter to a cantaloupe farm reveals FDA’s use of the principles found in its new Proposed Rule for Standards of Produce Safety, recently issued on January 4, 2013 under the Food Safety Modernization Act (FSMA). The Warning Letter,...
On Friday, January 4, 2013, the U.S. Food and Drug Administration (“FDA”) issued a Proposed Rule which proposed revisions to the current Good Manufacturing Practices (“cGMPs”) requirements for foods along with proposing the regulation for Hazard Analysis and...
The U.S. Food and Drug Administration (“FDA”), for the first time in its history, formally entered into regulating how food is grown and harvested by proposing standards for the safe growing, harvesting, packing, and holding of produce on farms. The Food Safety...
On January 4, 2013, FDA published its proposed Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) regulations for food facilities, exactly one year after it was required to under the Food Safety Modernization Act (“FSMA”). HARPC is a new set of food safety...
After a full year’s delay the U.S. Food and Drug Administration has finally released some key proposed rules due under the 2011 Food Safety Modernization Act. These proposed rules include (click on each to learn more): 1. Hazard Analysis and Risk-Based Preventive...
The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the...
What a year! A lot of water has gone under the regulatory bridge- from the Carbendazim issue with Brazilian OJ to the “pink slime” media fiasco to FSMA and Chinese imports. Here are our top 10 most popular blog posts from 2012 (most popular first). Thanks to...
The FDA regulatory consultants and affiliated attorneys at FDAImports.com recently achieved another success for one of their clients, obtaining removal from an FDA Import Alert for cosmetics. The client, a Chinese cosmetic firm, was placed on FDA Import Alert 53-06,...
Imagine a government official approaching you outside your business one afternoon. The official demands that you empty your pockets. You refuse and ask why. “Because you appear to have contraband in your pockets.” When you ask what evidence he has he answers, “I’m...
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