New and Revised FDA Import Alerts for Dec. 22
On Dec. 22, 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 GUDID Record (here)
- 99-46: Imported Human Foods due to Filth (here)
- 99-45: Food Products that are or Contain an Unsafe Food Additive (here)
- 99-43: Ready-to-Eat Human (RTE) Food Products that appear to have been Prepared, Packed or Held Under Insanitary Conditions (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)
- 99-34: Drugs or Medical Devices from firms without a valid Drug or Medical Device Registration (here)
- 99-22: Foods Containing Undeclared Major Food Allergens or Foods that fail to Properly Label Major Food Allergens (here)
- 99-19: Food Products due to the Presence of Salmonella (here)
- 99-08: Processed Foods for Pesticides (here)
- 99-05: Raw Agricultural Products for Pesticides (here)
- 89-08: Class III Devices Without Approved PMAs or IDEs and Other Devices Not Equivalent or No 510k (here)
- 80-04: Surgeon's and Patient Examination Gloves (here)
- 68-19: Unapproved New Animal Drugs (here)
- 66-41: Unapproved New Drugs Promoted in the U.S. (here)
- 53-06: Cosmetics That are Adulterated and/or Misbranded due to Color Additive Violations (here)
- 45-02: Foods Containing Illegal and/or Undeclared Colors (here)
- 23-15: Food Products that are, or that contain, Areca (Betel) Nuts, Including Finished Dietary Supplements and Bulk Dietary Ingredients (here)
- 22-01: Cantaloupes from Mexico (here)
- 16-129: Seafood Products due to Nitrofurans (here)
- 16-124: Aquaculture Seafood Products due to Unapproved Drugs (here)
- 16-120: Fish/Fishery Products from Foreign Processors (Manufacturers) not in compliance with Seafood HACCP (here)
- 16-119: Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations (here)
- 16-105: Seafood and Seafood Products from Specific Manufacturers/Shippers due to Decomposition and/or Histamines (here)
- 16-74: Uneviscerated Fish or Partially Eviscerated Fish that are Either Salt-Cured, Dried, Smoked, Acidified, Pickled, Fermented or Brined (here)
- 12-10: Cheese due to Microbiological Contamination (here).