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.
On March 21 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 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.
On March 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 19 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 March 19 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 will allow more time for comments on two proposals related to the Food Safety Modernization Act, it said on March 19. FDA said it will extend until June 30 the period for comments on its Food Safety Modernization Act (FSMA) proposed rule on the intentional adulteration of food (see 13122017). It is also extending until May 22 the period for comments on proposed criteria for designation of high-risk foods that will be subject to heightened recordkeeping requirements (see 14020318). The agency said the extensions will be formally announced soon in the Federal Register.
The Food and Drug Administration threatened to refuse admission to fish products from three New York importers, in separate warning letters sent in early March. The agency said fish products from Han Sung Sikpoom Trading Co., Hong Lee Trading Inc., and Russian Products, Inc. failed to meet seafood hazard analysis and critical control point standards (HACCP). FDA said it sampled fish products imported by each company, and refused admission because of HACCP violations.
On March 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: