FDA’s Proposed Changes to current Good Manufacturing Practices for Foods Rearrange Old Rules While Imposing Important New Requirements and New Costs
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...
Proposed Regulatory Standards for Produce Safety Under FSMA: FDA Begins to Regulate Farms
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...
FDA Publishes Proposed HARPC Rules: Food Facilities Take Note!
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...
Breaking News: FDA Finally Issues HARPC, Produce Safety Proposed Rules
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...
Medical Device Manufacturers Registration Renewal Deadline Pushed to January 31, 2013
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...
Happy Holidays 2012 from the FDAImports.com Team
Wishing all of our friends, clients, partners and their families a wonderful holiday season! - Ben, Rick, Bill, John, Ryan, Celeste, Tom, Anne, Shelly, Eva, Anna, Jon, Graham, Amanda, Jenn and Alison *Please note that the offices of FDAImports and Benjamin L. England...
Food Facility Registration Deadline: Enforcement Discretion Does Not Mean Procrastination!
By now food manufacturers should be more than aware of the new Biennial Food Facility Registration requirement set forth under the Food Safety Modernization Act (If not, read this NOW). Though registration is a relatively painless process, it can be time-consuming...
Our Top 10 Most Popular Blog Posts of 2012
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...
Another FDA Import Alert 99-29 Success Story: FDAImports.com Obtains Green List Status for Chinese Company
The FDAImports.com team achieved another Import Alert success, this time obtaining a green ticket for a Chinese firm for FDA Import Alert 99-29, “Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to...
FDAImports.com Obtains FDA Import Alert 53-06 Removal for Cosmetics Client
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,...