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New and Revised FDA Import Alerts for March 8

On March 8, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

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  • 99-46: Imported Human Foods due to Filth (here)
  • 99-35: Fresh Produce that appears to have been Prepared, Packed or Held Under Insanitary Conditions (here)
  • 89-08: Class III Devices Without Approved PMAs or IDEs and Other Devices Not Equivalent or No 510k (here)
  • 66-66: Active Pharmaceutical Ingredients (APIs) that appear to be Misbranded Under 502(f)(1) Because they do not meet the Requirements for the Labeling Exemptions in 21 CFR 201.122 (here)
  • 66-41: Unapproved New Drugs Promoted in the U.S. (here)
  • 21-17: Papaya from Mexico (here)
  • 16-119: Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations (here).