On Aug. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Aug. 7 that 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.
The Food and Drug Administration should reinstate unannounced inspections of drug manufacturing facilities outside the U.S., Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said in a letter to the agency Aug. 6. Grassley said he brought the issue up since the administration is considering regulations that would allow drug importation from Canada in order to help drive down the prices of prescription drugs (see 1907310018). He noted that the FDA does not keep records of whether inspections were unannounced or planned in advance, and that the agency told him that they generally do not do unannounced visits abroad, though they do domestically. "[I]n 2013 the FDA created a pilot program in India that eliminated advanced notice and instead used short notice or unannounced visits. The pilot program also arranged for FDA inspectors’ travel to be arranged through the U.S. embassies instead of through FDA offices or manufacturer-arranged travel plans to provide more secrecy in the lead-up to inspections," Grassley wrote. "According to reports, the new inspection regime 'exposed widespread malfeasance' that had otherwise been hidden because of the advanced warning system." For instance, inspectors found fake laboratories and missing samples. The pilot program ended in 2015, and Grassley thinks it should not have.
The Food and Drug Administration looks set to ramp up enforcement of Foreign Supplier Verification Program requirements for food importers, after creating a new import alert on July 31 for importers that aren’t compliant with the regulations. Import Alert 99-41 provides for FDA detention without physical examination of human or animal food offered for import by importers listed on the import alert’s red list. No importers have been listed as of press time.
On Aug. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 31 and Aug. 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration set potential fiscal year 2020 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA 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. The agency set FY20 fees of $258/hour for domestic services involving travel and $301/hour if foreign travel is required. The fees are effective Oct. 1.
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:
The Food and Drug Administration is amending its color additive regulations to allow for the use of soy leghemoglobin to color ground beef analogue products, it said. The change was requested by Impossible Foods, Inc. The final rule takes effect Sept. 4.