On May 23 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 needs more resources to finish implementing Food Safety Modernization Act programs and regulations, it said in a report to Congress. The report outlined FDA's FSMA mandates, as well as progress on implementation made to date. “The promise of FSMA to modernize the food safety in the U.S. and to significantly reduce the burden of foodborne illness cannot be realized without additional funding,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in remarks made in conjunction with the release the report.
On May 22 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 May 22 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is considering refusing admission of imports of active pharmaceutical ingredients (APIs) and finished pharmaceuticals from Boehringer-Ingelheim Pharma’s Ingelheim am Rhein, Germany facility. According to an FDA warning letter, an agency inspection found serious violations of current good manufacturing practice requirements for both types of products at the facility.
The Food and Drug Administration is taking steps to refuse admission of Rubimed’s REBA Feedback Devices, after discovering that the Switzerland-based company does not have a valid approved premarket approval application for the device, the agency said in a warning letter dated May 6. The device will be put on detention without physical examination for the violations, which also include deviations from current good manufacturing practices and failure to comply with Medical Device Reporting requirements, FDA said.
On May 20 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 May 14-20, 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 May 17-19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: