Is it ever legitimate for FDA to add companies to an FDA import alert without notice? No. Does FDA do this anyway? Yes, and frequently. In April 2013, many Chinese OTC drug manufacturers fell victim to FDA’s caprice. In 2012, FDA conducted a series of surprise...
FDA may be having some trouble with its regulations.gov website, but it still wants to hear from industry on proposed rules. FDA had extended the comment period for the FSMA proposed rules for produce safety and preventive controls for human foods to November 15th,...
Benjamin L. England, founder and CEO at FDAImports.com, honored to be invited as a recognized expert in the field of Tilapia, will be speaking on the expert panel in the 10th International Tilapia Industry Development Forum (Venue: Dalian Xinghai Convention &...
Shuttered up and closed - the government shutdown was painful for many U.S. businesses. This was especially true for any business having to deal with FDA. FDA lost over 50% of its employees during the shutdown. Many of those furloughed were investigators and internal...
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...
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...
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...
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...
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...
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...
Get up-to-date industry and regulatory news from the experts delivered straight to your inbox.