New and Revised FDA Import Alerts for Nov. 6
On Nov. 6, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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- 99-42: Foods due to Heavy Metal Contamination (here)
- 99-39: Imported Food Products that appear to be Misbranded (here)
- 89-08: Class III Devices Without Approved PMAs or IDEs and Other Devices Not Equivalent or No 510(k) (here)
- 66-79: Drugs from Foreign Establishments Refusing FDA Inspection (here)
- 66-57: Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S. (here)
- 66-41: Unapproved New Drugs Promoted in the U.S. (here)
- 62-08: Alcohol-Based Hand Sanitizers Manufactured in Mexico (here)
- 55-05: Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination (here)
- 55-03: Different Forms of Heparin and Heparin-Related Products (here)
- 54-07: Germanium Products (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).