The Food and Drug Administration posted to its website draft changes to its guidance on prior notice for imported foods. The agency hasn’t updated the questions and answers document since 2004, and in the meantime formally adopted the interim final rule that established prior notice requirements and issued another final rule requiring importers notify FDA if an article has previously been refused entry. Comments on the draft guidance may be submitted at any time, but should be filed by May 30 for consideration before FDA finalizes the guidance, said FDA in a concurrent Federal Register notice (here).
On March 27 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’s Denver district office will host a public workshop June 23-24 in Denver on “a number of topics” related to FDA’s regulation of drugs and medical devices. The “FDA and Global Engagement: Progress on the Pathway to Global Product Safety” workshop, a joint effort between FDA and the Association of Food and Drug Officials, will include information on contract manufacturing, compliance, recalls, and international regulations, said FDA. Registration is required by May 23, and costs $575 for non-association members. Hotel reservations must be made by May 21 to receive the reduced conference rate.
The Food and Drug Administration issued its weekly Enforcement Report for March 26 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 24 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 March 17-23, 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 asking for comments on the implementation of new reporting requirements under the Food Safety Modernization Act (FSMA). The law says human and animal food facilities that are required to register with FDA have to submit consumer-oriented information to the agency for “reportable foods” that can be dangerous to human or animal health. FDA would then publish the information on its website, and the information may also be required to be provided to consumers by grocery stores. As an initial step in the implementation process, FDA is seeking comments on the information that should be provided and how that information should be passed onto consumers. Comments are due by June 9.
The Food and Drug Administration’s Los Angeles District on March 17 updated its list of phone numbers and communication procedures for its import operations branch. The list includes contact info for questions about specific entries, as well as prior notice and facility registration requirements. It also includes procedures for using FDA’s automated systems, and guidelines for sending emails to FDA L.A. The document says the district office will now accept private lab reports via electronic PDF copies.