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New and Revised FDA Import Alerts for Oct. 17

On Oct. 17, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of:

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  • 99-19: Food Products due to the presence of Salmonella (here)
  • 95-05: Electronic Products that fail to comply with Performance Standards or to have Required Certification (here)
  • 89-08: Devices without approved PMAs or IDEs and other Devices not substantially equivalent or without a 510(k) (here)
  • 89-04: Devices from firms that have not met Device Quality System Requirements (here)
  • 76-01: Medical Instruments from Pakistan (here)
  • 66-41: Unapproved New Drugs Promoted in the U.S. (here)
  • 45-02: Foods containing Illegal and/or Undeclared Colors (here)
  • 16-74: Uneviscerated Fish or Partially Eviscerated Fish that are either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (here)
  • 16-125: Refrigerated (not frozen with proper labeling) Raw Fish and Fishery Products in reduced oxygen packaging due to the potential for Clostridium Botulinum Toxin Production (here).