On July 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 published its tentative schedule for upcoming rulemakings, as part of the Spring 2013 Unified Agenda. According to the plan, proposed rules on the Foreign Supplier Verification Program and third-party food safety auditor accreditation, required by the Food Safety Modernization Act, are to be published in July 2013. As of July 22, both proposed rules are still under Office of Management and Budget Review.

On July 18 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 July 17 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The Food and Drug Administration posted its draft guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug facility inspection, as required be Food and Drug Administration Safety Improvement Act (FDASIA). Under the 2012 law, FDA can seek criminal penalties for delaying, limiting, or refusing drug facility inspections, and can deem the associated product adulterated in such instances.

On July 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On July 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 may block imports from Dominican Republic-based Sabila SRL because of violations of acidified foods and current good manufacturing practice regulations, it said in a July 1 warning letter sent to the company. An FDA inspection in December 2012 found the problems, which include deficient records, poor pest control, and insufficient plumbing, the warning letter said. Because the issues are materially related to food safety, FDA will charge reinspection fees when it goes back to see if the problems have been fixed. The warning letter said the firm should consider informing its U.S. agent of the potential fee liability.

On July 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 will reinstate the right of Anneri and Yuri Izurieta to import food, withdrawing two debarment orders in response to a February 2013 court decision overturning criminal penalties against the two Florida residents. The two had been barred from importing for 30 and 20 years, respectively, after the Southern Florida U.S. District Court found them guilty of criminal charges related to their failure to redeliver tainted food (see 12012706). But the U.S.11th Circuit Court of Appeals overturned the conviction in February, saying that 19 CFR 141.113 redelivery violations aren’t subject to criminal penalties (see 13022503 and 13030718). FDA said it is withdrawing its debarments (here) and (here) because the court order vacating the criminal charges removed the basis for the prohibitions.