This week the Food and Drug Administration (FDA) was required to submit the final rule for the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for publication in the Federal Register. According to FDA, this was completed on August 31, but curiously FDA has...
Don’t Wait to Act Until FDA Adds the Company to Import Alert Waiting until you get red-listed before identifying what happened and fixing it is a big time-and-money mistake. However, if you wait until your company is added to an import alert, you will likely have a...
FDA’s electronic import entry review systems will be down for major upgrades from this Saturday, May 9, 2015 at 1:00 am EDT until Sunday, May 10 at 1:00 am EDT. This will impact primarily food imports and perishable imports. In addition to Prior Notices submitted...
Worldwide Ramifications Unclear Until FDA Releases New Import Criteria for Methyl Mercury The U.S. Food and Drug Administration (FDA) confirmed today that the agency cancelled Import Alert number 16-08. According to FDAImports.com's daily-tracking records on...
Maryland-based FDA consulting firm FDAImports.com is proud to announce the expansion of its California office, adding Richard Chiang, former Compliance Supervisor for the Import Operations Branch of the FDA Los Angeles District Office. Richard Chiang, Senior...
For the fourth consecutive year, FDAImports.com has been featured at the China Fisheries and Seafood Expo. This year the show was held November 5 to 7, 2014 in Qingdao, with Benjamin England, Rick Quinn, Shelly Li, and Ge Song in attendance. “We were very fortunate to...
The FDAImports.com and ExportToUsa.com.cn consultants are exhibiting again at the 2014 19th China Fisheries & Seafood Expo at the Qingdao International Convention Center, from November 5-7. “One focus for us this year will be the transfer of authority on catfish...
While generic drug laws and policy have brought down the cost of Rx drugs for many Americans, recent legislation, such as the Generic Drug User Fee Amendments of 2012 (GDUFA) is reversing that trend and significantly increasing the cost of generic drugs. GDUFA added...
FDAImports.com recently obtained removal for a manufacturer from Import Alert 66-41 (automatic detention of unapproved new drugs promoted in the U.S.). Under this Import Alert FDA detains all products it deems “unapproved new drugs” – even if they’re merely cosmetics...
Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with FDANews, entitled “Thinking Ahead of FDA: Preventive care tips for your FDA import compliance program.” Mr. England said, “Up to now, FDA has been mostly reactionary in its enforcement...
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