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:
FDA Will Charge Reinspection Fees, May Block Imports from Dominican Republic Acidified Food Facility
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.
On July 12 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 announced the final version of a compliance policy guide on salmonella-contaminated food for animals. The document sets FDA staff criteria for enforcement actions against contaminated animal food, including animal feed and pet food. As of press time, the new guide is unavailable on FDA's website, but the agency said it will be posted (here).
On July 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 10 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 10 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 no longer allow use of bisphenol A-based epoxy resins as coatings in infant formula packaging, according to a final rule that takes effect July 12. The agency said it’s removing the approved use from its food additive regulations at 21 CFR 175 because the chemical is no longer used by the industry, and not because of safety concerns. “FDA’s action is based solely on a determination of abandonment and is not related to the safety of BPA,” FDA said in a press release (here). “The agency’s current safety review supports the safety of BPA for use in the manufacture of food contact articles as authorized in the food additive regulations,” it said.