New and Revised FDA Import Alerts for Nov. 8
On Nov. 8, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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- 99-39: Imported Food Products that appear to be Misbranded (here)
- 99-34: Drugs or Medical Devices from firms without a valid Drug or Medical Device Registration (here)
- 99-23: Produce due to Contamination with Human Pathogens (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)
- 66-41: Unapproved New Drugs Promoted in the U.S. (here)
- 66-40: Drugs from firms which have not met Drug Good Manufacturing Practices (GMPs) (here)
- 54-14: Dietary Supplement Products from firms which have not met Dietary Supplement Good Manufacturing Practices (GMPs) (here)
- 54-07: Germanium Products (here)
- 25-21: Enoki Mushrooms from South Korea due to Listeria Monocytogenes (here).