New and Revised FDA Import Alerts for Aug. 15
On Aug. 15, 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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- 99-43: Ready-to-Eat Human (RTE) Food Products that appear to have been Prepared, Packed or Held Under Insanitary Conditions (here)
- 99-39: Imported Food Products that appear to be Misbranded (here)
- 99-38: Low-Acid Canned Foods or Acidified Foods due to Inadequate Process Control (here)
- 95-05: Electronic Products that fail to comply with Performance Standards or Have No Certification (here)
- 95-04: Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, and Similar Products that fail to comply with applicable Performance Standards and Reporting Requirements (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)
- 68-20: Xylazine Active Pharmaceutical Ingredient (API) and Unapproved Finished Drug Products containing Xylazine (here)
- 66-79: Drugs from Foreign Establishments refusing FDA Inspection (here)
- 66-41: Unapproved New Drugs promoted in the U.S. (here)
- 45-02: Foods Containing Illegal and/or Undeclared Colors (here).