New and Revised FDA Import Alerts for Sept. 1
On Sept. 1, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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- 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)
- 99-19: 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)
- 86-11: Contact Lenses due to Microbiological Contamination (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).