TUCSON, Ariz. -- Filing of Food and Drug Administration entries in the ACE continues its rapid rise, with the latest data from the agency showing a “high percentage” of filers using ACE and the number of entries filed in the system “drastically” increasing since January, said Dominic Veneziano, director of FDA’s Division of Import Operations, at the National Customs Brokers & Forwarders Association of America annual conference on April 19.
On April 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 on April 18 issued an import alert authorizing its district offices to hold all shipments of aquacultured shrimp and prawns from peninsular Malaysia (here). The alert follows FDA testing that showed an increase in already high levels of animal drugs, with nearly one-third of sampled shipments testing positive, said FDA in a constituent update (here). FDA had been placing Malaysian companies individually on import alert. The alert does not apply to the Malaysian states of Sarawak and Sabah, and importers should provide documentation declaring the source farm if they bring in shrimp from one of these two states. If an importer finds its shipment has been held under the alert, the owner or consignee should provide the results of a private laboratory analysis showing a sample collected from the shipment does not contain any residues of nitrofuran or chloramphenicol. Malaysian companies may be placed on a “green list” of firms exempt from the import alert supporting its request to FDA, including whether it has appropriate controls and processes in place to prevent the appearance of future residues, said FDA.
On April 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 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 issued its weekly Enforcement Report for April 13 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
The Food and Drug Administration on April 14 posted a guidance document on current good manufacturing practices, quality control procedures, conduct of audits and records and reports for infant formulas exempt from normal requirements (here). Infant formulas are exempt from FDA’s standards if they are labeled for use by an infant with metabolism errors, low birth weight or other unusual medical or dietary problems. Despite the exemption, manufacturers should attempt to follow standards for non-exempt formula “to the extent practicable,” said FDA in the guidance. Comments on the guidance may be submitted at any time, said FDA (here).
On April 13 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 is amending its food additive regulations to allow the use of folic acid as an additive in corn masa flour, in a final rule (here). The level of folic acid may not exceed 0.7 milligrams per pound of flour, said FDA. The new regulations take effect April 15, though written objections may be submitted until May 16.
The Food and Drug Administration is asking for input from industry as it develops its pilot program under the Drug Supply Chain Security Act, it said (here). The agency is interested in “issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established” under the 2013 law (see 13121725), it said.