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New and Revised FDA Import Alerts for Sept. 16

On Sept. 16, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

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  • 99-39: Imported Food Products that appear to be Misbranded (here)
  • 89-08: Class III Devices without approved PMAs or IDEs and Other Devices Not Equivalent or No 510k (here)
  • 79-01: Topical/External Bandages, Dressings, Gauzes/Sponges and Cotton Pads due to Microbiological Contamination (here)
  • 66-79: Drugs from foreign establishments refusing FDA Inspection (here)
  • 45-02: Foods Containing Illegal and/or Undeclared Colors (here).