On Aug. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 14 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. 14 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 is issuing a proposed rule that would set new required cigarette health warnings for cigarette packages and advertisements. Required by the 2009 Tobacco Control Act, the proposed regulations would require that each cigarette package and advertisement bear color graphics depicting the negative health consequences of smoking, as well as new textual warning statements. The proposal would apply to domestically manufactured and imported cigarettes. FDA is proposing that the new requirements take effect 15 months after the final regulations are issued. Comments are due Oct. 15.
On Aug. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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.