On July 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA's weekly Enforcement Report for July 29 lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
FDA set potential fiscal year 2021 fees for import reinspections, domestic and foreign facility reinspections, and recall activities the agency performs if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, it said in a notice released July 31. The agency set FY21 fees of $263/hour for domestic services involving travel and $310/hour if foreign travel is required.
FDA is proposing changes to its regulations that would require electronic filing in ACE of partner government agency (PGA) data for veterinary devices. The agency’s proposed rule would require filers of entries of veterinary devices to transmit the (1) FDA Country of Production; (2) complete FDA Product Code; (3) full intended use code; (4) and telephone number and email address of the importer of record. “These data elements are currently required to be submitted for the electronic filing of entries containing food contact substances, drugs, biological products, [human cells, tissues or cellular- or tissue-based products (HCT/Ps)], medical devices for human use, radiation-emitting electronic products, cosmetics, and tobacco products,” FDA said. Comments are due Oct. 18.
On July 29 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA will set the fiscal year 2021 fee for its Voluntary Qualified Import Program at $17,000, it said in a notice. The fee, which is up from $16,681 last year, is required from food importers to begin participation in the VQIP trusted trader program for the period beginning Oct. 1, 2020, FDA said. The fee will remain in effect through Sept. 30, 2021, it said. FDA has only approved one participant for VQIP's FY20 program period, and experts have said the program's high cost, coupled with unclear benefits, are behind the lack of concrete interest among food importers (see 2004100055).
On July 28 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 27 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 24 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 23 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: