New and Revised FDA Import Alerts for May 28
On May 28 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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- 89-08: Devices without Approved PMAs or IDEs and Other Devices Not Substantially Equivalent or Without a 510(k) (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)
- 66-10: Chinese Herbal Medicines (here)
- 36-04: Honey and Blended Syrup due to Unsafe Drug Residues (here)
- 23-12: Coconut due to the Presence of Microbiological Contamination (here)
- 21-17: Papaya from Mexico (here)
- 16-35: Raw and Cooked Shrimp from India (here).