New and Revised FDA Import Alerts for Nov. 21
On Nov. 21, 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: Products imported by Debarred Entities (here)
- 99-49: Devices without a Unique Device Identifier (UDI) and/or Matching FDA Global Unique Device Identification Database (GUDID) Record (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)
- 99-05: Raw Agricultural Products for Pesticides (here)
- 98-06: New Tobacco Products without required Marketing Authorization (here)
- 89-08: Class III Devices without approved PMAs or IDEs and Other Devices Not Equivalent or No 510k (here)
- 89-04: Devices from firms that have not met Device Quality System Requirements (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).