Did you know that your imported entry of food can be refused admission into the United States if it appears that you failed to comply with the requirements of the Foreign Supplier Verification Program (FSVP)? Over the course of the last five years, FDA’s mantra has...
It has been nearly five years since FDA began inspections under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) regulations. Based on inspectional data from FDA’s Data/Compliance Dashboard for the last three years (2019-2022...
Update 06/03/2022: The next food facility registration renewal period begins October 1st and continues through December 31st. In preparation for this upcoming renewal season, FDA recently began validating the UFI status of existing registrations. The information...
Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been...
The Food & Drug Administration (FDA) has begun to apply Import Alert 99-29, "Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs," to imported...
In 2012 FDAImports represented a Chinese primary vegetable protein processor to obtain the first Green Ticket from the Food and Drug Administration's (FDA) Import Alert (IA) #99-29. Since then, multiple other Chinese vegetable protein processors have obtained a Green...
UPDATE on Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Original Post Sept 9, 2020: On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of...
On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it...
On May 22, 2020 the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced their recommendations to deal with shortages during the COVID-19 pandemic for cloth face coverings, sanitation supplies, disinfectants and personal...
The Emergency Use Authorization (EUA), together with the Food and Drug Administration’s (FDA’s) guidance on COVID-19-related enforcement discretion, were put in place so medical product manufacturers, importers, and distributors can bring certain devices and OTC drugs...
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