New and Revised FDA Import Alerts for Dec. 1
On Dec. 1, 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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- 99-50: Product imported by Debarred Entities (here)
- 99-38: Low-Acid Canned Foods or Acidified Foods due to inadequate Process Control (here)
- 99-34: Drugs or Medical Devices from firms without a valid Drug or Medical Device Registration (here)
- 98-06: New Tobacco Products, other than electronic nicotine delivery systems, or ENDS, without required Marketing Authorization (here)
- 89-08: Devices without approved PMAs or IDEs and other devices not substantially equivalent or without a 510(k) (here)
- 66-41: Unapproved New Drugs promoted in the U.S. (here)
- 45-02: Foods containing Illegal and/or Undeclared Colors (here)
- 16-125: Refrigerated (not frozen) Raw Fish and Fishery Products that are vacuum packaged or modified atmosphere packaged or packaged in a material that is not Oxygen-Permeable due to the potential for Clostridium Botulinum Toxin Production (here)
- 16-81: Seafood Products due to the presence of Salmonella (here)
- 16-74: Uneviscerated Fish or Partially Eviscerated Fish that are either Salt-Cured, Dried, Smoked, Acidified, Pickled, Fermented or Brined (here).