Two fish importers in New York have been put on notice by the Food and Drug Administration that their products may be refused admission at the border. Galil Importing Corp. of Syosset (here) and Eddie's Place (dba Esther Kwakyewa) of the Bronx (here) were each recently sent warning letters detailing alleged violations of seafood hazard analysis and critical control point (HACCP) regulations.
The Food and Drug Administration posted to its website information requesting exceptions from provisions of its new rules on unique device identifiers (UDIs) for medical devices (see 13092020). The webpage includes information on requests for exceptions or alternatives to UDI requirements; time extensions for applicability of UDI rules to Class III devices; and continued use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) codes. FDA is phasing in UDI requirements over a six-year period, with the first requirements for Class III devices taking effect in September 2014.
On May 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 May 14 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 is formally reclassifying intravascular administration set air removal systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 4. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Anesthesia Safety Products, LLC related to the AirPurge System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Air removal systems will not be exempt from premarket notification requirements.
The Food and Drug Administration announced the reclassification of colon capsule imaging systems as Class II medical devices subject to special controls. Colon capsule imaging systems were previously classified in Class III and required premarket approval. The reclassification took effect Jan. 29; FDA’s final order merely codifies it into regulation. Although they will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to testing, biocompatibility, and labeling.
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).