Want to Avoid an FDA Inspection? Inspect Yourself First
This post was contributed by FDAImports.com Regulatory Consultant, Walt Brittle Recently, Dan Starks, CEO of St. Jude Medical, Inc., announced to the media and investors that their Sylmar plant would likely receive a Warning Letter in response to an inspection...
How to Avoid Additional Lab Testing with FDA: An FDAImports.com Success Story
This post was contributed by FDAImports.com Senior Regulatory Advisor, Tom Knott FDAImports.com recently saved a U.S importer of medical components the substantial cost of unnecessary laboratory testing for one of their products. When the U.S. Food and Drug...
Rick Quinn to Participate in Expo West “Defining Natural” Panel Discussion and Town Hall Event
Rick Quinn, Principal at Maryland based FDA consulting firm, FDAImports.com, will be serving as a panelist at the Natural Products Expo West Town Hall meeting for retailers, “Defining Natural Together” on Sunday, March 10th, 2013 at 9am Pacific Time. The session,...
FDAImports.com Opens Chennai, India Office, Expands FDA Compliance Services, Offerings
FDAImports.com has opened an office in Chennai, India, a major commercial and economic hub located in Tamil Nadu, India. India, with significant exports of rice, wheat, sugar, seafood and other FDA-regulated products, is a major trade partner with the United States...
What Evidence? FDA Issues Administrative Detention of Food Final Rule, Carte Blanche Power Here to Stay
The U.S. Food and Drug Administration recently announced its Final Rule for the Administrative Detention of Foods under the Food Safety Modernization Act (FSMA). The rule adopts the Interim Final Rule from May 2011 without change. With this Final Rule, FDA now has...
Talking About the Food Safety Modernization Act is a Mouthful. Here’s the Outtakes Reel to Prove it
Talking about the Food Safety Modernization Act is hard work. It’s hard to understand, hard to pronounce, hard to summarize and even harder to have some fun with. But it’s what we do at FDAImports.com all the time. Although our final videos appear poignant and...
New Video: Impact of FSMA Proposed Rules on Importers and Foreign Suppliers
In this new FSMA training video, Ben England, Founder and CEO of FDAImports.com, shares his unique insights into the recently released Proposed Rules for HARPC and Standards for Produce Safety under FSMA with an eye toward their impact on importers and foreign...
New Video: What You Probably Missed in the Standards for Produce Safety Proposed Rule
As part of a new FSMA video series, Ben England, Founder and CEO of FDAImports.com, makes some valuable observations on the Proposed Rule for Standards for Produce Safety and explores some ways that industry can begin aligning themselves with FDA’s thinking. Food...
New Video: Four Key Insights Into the New HARPC Proposed Rule (FSMA)
By now the food industry should have a general grasp of the new Proposed Rules for HARPC and Standards for Produce Safety released by FDA this January 4th under FSMA. If you are looking for an overview please read these blogs on HARPC, Produce Safety and cGMP changes...
Will Prop 65 Kill Off BPA Forever? Second Time’s a Charm
California’s Prop 65 monster must be fed and this time it has set its hungry sights on BPA, the notorious chemical used in the production of plastics and epoxy resins for food and drink packaging. If listed, companies using BPA should consider phasing out their...