On Sept. 17 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 Sept. 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Sept. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Sept. 7-13, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Sept. 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 on Sept. 15 issued a final rule that makes it easier for the agency to destroy small shipments of illegal prescription drugs imported via international mail or express courier (here). The new regulations would allow FDA to destroy drug shipments valued at $2,500 or less that have been refused admission to the U.S., without giving the consignee the option of exporting the drugs. FDA is still required to give notice to the owner or consignee and the opportunity to request a hearing. The final rule takes effect Oct. 15.
On Sept. 11 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 final rule setting new current good manufacturing practice and preventive controls requirements for animal food (here). Set to be published in the Sept. 17 Federal Register alongside FDA’s final rule on preventive controls for human food (see 1509100021), the final rule sets CGMP requirements and mandates a written preventive controls plan similar to that for human food for animal food facilities require to register with FDA. The new regulations include exemptions, including for small businesses. Importers of animal foods would have to verify their foreign suppliers’ compliance with these CGMP and preventive controls regulations as part of the Foreign Supplier Verification Program.
On Sept. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: