US Trading Company is recalling batch of chili powder imported from Thailand because of the presence of Salmonella, said the Food and Drug Administration March 13. The chili powder comes in a 6.3 ounce clear plastic tub. The bar code 7 21557 53317 8 is printed on the front of the tub. The code 359XP is affixed to the bottom of the container. FDA said it found the problem in a lot of chili powder during routine sampling. Production and distribution of the product have been suspended while FDA, the California Department of Public Health, and US Trading continue the investigation, it said.
On May 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 announcing updates to its list of standards FDA recognizes for use in premarket reviews of medical devices (FDA recognized consensus standards). This publication, titled "Modifications to the List of Recognized Standards, Recognition List Number: 035," will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices, said FDA.
The Food and Drug Administration’s Center for Tobacco Products is moving a few miles down the road from Rockville, Maryland. to the agency’s main White Oak campus in Silver Spring. FDA says the move will begin around June 6, and will take about three weeks. All physical correspondence with the Center for Tobacco Products should be addressed to the new address beginning on June 6. More information is available (here).
The Food and Drug Administration will expand cooperation with European regulators on pharmaceuticals, in an initiative announced in May 12 by Howard Sklamberg. FDA will be deploying a “dedicated FDA team to work with our European counterparts on a host of issues,” he said. The team will include officials from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Office of Global Regulatory Operations and Policy. “Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection,” said Sklamberg.
On May 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 posted a new draft guidance on the use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. The draft guidance also proposes two changes in policy, the first being that declarations of conformity would no longer be used when the submitter deviates from an FDA standard, and the second being that promissory statements indicating future compliance with a consensus standard would no longer be used. Comments on the draft guidance are due Aug. 11, said FDA in a concurrent Federal Register notice (here).
On May 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
A French company is recalling cheese it exported to the U.S. after the Food and Drug Administration found contamination by salmonella. Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses, lot number 350. The products were distributed nationwide in supermarkets and gourmet stores between March 10 and May 6, said FDA.Both kinds of cheese come as a 13lb wheel and are usually cut and wrapped, said FDA. FDA said it found the salmonella bacteria in some of Ste Fromagere du Livradois’ products during routine sampling. No illnesses have been reported to date, it said.
The Food and Drug Administration on May 8 posted to its website two updated guidance documents intended to assist with compliance with the agency’s new requirements for unique device identifiers (UDIs) on the labels of medical devices and device packages. Under FDA’s September 2013 final rule, the UDI system will be phased in over a seven year period, with marking of class III devices required by September 2014, class II devices by 2016, and class I and all other devices by 2018 (and for reusable devices, on the class I device itself by 2020) (see 13092020). The "GUDID Data Elements Reference Table: (here) summarizes device attribute information that will populate the Global Unique Device Identification Database (GUDID). “UDI Formats by FDA-Accredited Issuing Agency” (here) summarizes the UDI formats for the issuing agencies that FDA has accredited to date.