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New and Revised FDA Import Alerts for Oct. 10

On Oct. 10, 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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  • 99-49: Devices without a Unique Device Identifier and/or Matching Global Unique Device Identification Database (GUDID) record (here)
  • 99-42: Foods due to Heavy Metal Contamination (here)
  • 99-41: Human and Animal Foods Imported from Foreign Suppliers by Importers who are not in compliance with the requirements of the Foreign Supplier Verification Program (FSVP) Regulation (here)
  • 99-39: Imported Food Products that appear to be Misbranded (here)
  • 99-35: Fresh Produce that appears to have been Prepared, Packed or Held Under Insanitary Conditions (here)
  • 99-05: Raw Agricultural Products for Pesticides (here)
  • 98-07: Electronic Nicotine Delivery Systems (ENDS) Lacking Premarket Authorization (here)
  • 76-01: Medical Instruments from Pakistan (here)
  • 66-66: Active Pharmaceutical Ingredients (APIs) that appear to be Misbranded Under 502(f)(1) because they do not meet the requirements for the Labeling Exemptions in 21 CFR 201.122 (here)
  • 66-41: Unapproved New Drugs Promoted in the U.S. (here)
  • 54-14: Dietary Supplement Products from firms which have not met Dietary Supplement Good Manufacturing Practices (GMPs) (here)
  • 16-124: Aquaculture Seafood Products due to Unapproved Drugs (here).