The FDA announced May 31 that it will in about six months begin requiring accreditation under its Laboratory Accreditation for Analyses of Foods (LAAF) regulation for laboratories testing for mycotoxins to support admissibility or removal from an import alert (see 2112020017).
A final rule that will allow the FDA to dispose of low-value medical devices and medicines more easily will take effect June 30. Currently, importers of medical devices valued at $2,500 or less have the option of re-exporting the device if it is barred from entering the U.S. In the case of drug shipments under that dollar threshold, the FDA has to prove the medicines are counterfeit, misbranded, adulterated or not approved in the U.S.; with the change, the agency will be allowed to destroy the drugs if it appears they are counterfeit, etc., unless the owner or consignee asks to testify on the medicines' admissibility.
On May 28, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 24, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 23, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 22, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of:
On May 21, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 20, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 17, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 16, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of: