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New and Revised FDA Import Alerts for Jan. 22

On Jan. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

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  • 89-08: Class III Devices Without Approved PMAs Or IDEs and Other Devices Not Equivalent or No 510k (here)
  • 89-04: Devices From Firms That Have Not Met Device GMPs (here)
  • 80-04: Surgeon's and Patient Examination Gloves (here)
  • 76-01: Medical Instruments from Pakistan (here)
  • 66-40: Drugs From Firms Which Have Not Met Drug GMPs (here)
  • 45-06: Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts (here)
  • 45-02: Foods Containing Illegal and/or Undeclared Colors (here)
  • 21-17: Papaya from Mexico (here)
  • 12-10: Cheese Due to Microbiological Contamination (here)