To Err Is Human: Successful Removal from Import Alert 86-07 Demonstrates that FDA can be Wrong, too
FDA makes mistakes just like everyone else, so don’t assume that FDA is always right. We experienced a case where FDA placed the wrong firm on Import Alert 86-07 (“Detention without Physical Examination of and Guidance of Impact-Resistant Lenses in Eyeglasses and...
Top 6 Imported Food Labeling Errors Causing FDA Detentions and Refusals
FDA cares about imported food labels, and so should you! Foreign food manufacturers often fail to realize the importance of having correct food labels on their imported food products. These simple food labeling mistakes can be costly and time-consuming for...
Is Your Device Subject to UDI Regulations?
On September 24, 2013, FDA passed the Final Rule for Unique Device Identifiers (UDI). With some exceptions, the regulation mandates that all medical devices must bear a UDI, which must be issued by FDA or an FDA-accredited issuing agency. FDA or the accredited...
California Department of Public Health and the Case of the Missing 5-Log Reduction
The California Department of Public Health (CDPH) has recently been chasing down the cold-press juice industry, citing companies for non-compliance with FDA's Juice Hazard Analysis and Critical Control Point (HACCP) regulations. According to CDPH, cold-press juice...
FDA Shutdown’s Effect on Food Safety: None.
In recent discussions, Ben England, Founder and CEO of FDAImports.com said: "This shutdown will be felt by the trade, but it will not impact food safety. As a general rule, FDA compliance officers are considered essential. Food recall coordinators are usually...
FDA Registration Renewal – It’s That Time Again
Did you know? If your medical device or drug facility is not registered (or renewed) by December 31, 2013, you may not be able to import products to the United States. The U.S. FDA requires any facility that handles an FDA-regulated good to register. Members of...
FDAImports.com Exhibiting at the 18th China Fisheries & Seafood Expo
The FDAImports.com and ExportToUsa.com.cn consultants are exhibiting again at the 2013 18th China Fisheries & Seafood Expo at the Dalian World Expo Center, from November 5-7. At the Expo, Fisheries Advances Magazines reporters will interview Benjamin England,...
What is “Inconspicuous” Labeling?
Did you know that FDA might take a ruler to measure your label and check if your type size matches their labeling specification? “Inconspicuous labeling” ranks number 4 among the most frequently used labeling charges in refused food entries. FDA cares about labeling...
Undeclared Allergens Caused 60 Percent of All Recent Food Recalls
Did you know that more foods were recalled due to labeling errors than pathogenic contamination during the last quarter? Based on a recent quarterly finding from Stericycle ExpertRECALL, Food Safety News reported that 60 percent of all FDA-monitored food recalls...
FSVP Video Series: Implications for Seafood and Juice HACCP
On July 26, 2013, FDA released the proposed regulations for the Foreign Supplier Verification Program (“FSVP”) as mandated by the Food Safety Modernization Act of 2010. In a video titled “FSVP Video Series Part 3: Implications for Seafood and Juice Industry” posted on...