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:
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 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:
The Food and Drug Administration added a new document type for "External Lab Analytical Package" in the Import Trade Auxiliary Communication Systems (ITACS), it said in a CSMS message. The FDA said it prefers to receive private lab results in electronic formats and can process electronically submitted results faster than hard copies.
On May 15 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 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On May 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 released a new tool to help owners and operators of food facilities -- ranging from production and manufacturing to retail and transportation -- develop customized plans to minimize the risk of intentional contamination at their individual food facilities. The Food Defense Plan Builder helps facility operators implement the optional plans through a series of questions about the user’s facility and associated food, FDA said. The plans include a vulnerability assessment, broad and focused mitigation strategies, and an action plan, it said. The content in the tool is based on FDA’s food defense guidance documents, and so are consistent with FDA’s current thinking on the issue, the agency said.
On May 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: