New and Revised FDA Import Alerts for Sept. 7
On Sept. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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- 99-19: Food Products due to the Presence of Salmonella (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)
- 72-03: Pig Ears and Other Pet Treats due to the Presence of Salmonella (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)
- 16-120: Fish/Fishery Products from Foreign Processors (Manufacturers) not in Compliance with Seafood HACCP (here)
- 12-10: Cheese due to Microbiological Contamination (here)
- 12-03: Imported Soft Cheese and Soft Ripened Cheese from France (here).