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New and Revised FDA Import Alerts for Sept. 13

On Sept. 13, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

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  • 66-76: Drugs or Active Pharmaceutical Ingredients from Facilities that have not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under Generic Drug User Fee Amendments (GDUFA) (here)
  • 16-120: Fish/Fishery Products from Foreign Processors (Manufacturers) not in Compliance with Seafood HACCP (here).