The Food and Drug Administration recently warned two seafood processors in Japan and India that it may begin refusing imports from the companies unless they correct violations of seafood hazard analysis and critical control point (HACCP) regulations. In a warning letter to Sushi Den Japan dated June 24 (here), FDA said the company lacks a HACCP plan for its bonito, yellowtail, spanish mackerel, and jack mackerel, and said it considers the fish adulterated as a result. FDA also sent a warning letter dated June 2 to Accelerated Freeze Drying in Cochin, India (here), alleging deficiencies in the company’s HACCP plans for freeze dried shrimp. FDA told both companies that, unless the violations are corrected, it would put fish products from the facilities on import alert and refuse admission. FDA also said it will have to reinspect the facilities to ensure compliance, and will charge the companies’ U.S. agents for reinspection.
The Food and Drug Administration is adjusting medical device user fees for fiscal year 2015, it said in a July 30 notice. The agency will decrease fees across the board, except for fees related to annual establishment registration, which are set to rise from $3,313 to $3,646. The new fees take effect Oct. 1, and will run until Sept. 30, 2015.
On July 24 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 23 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 reclassifying implanted blood access devices (here) and implantable transporstatic tissue retractor systems (here) as Class II devices that do not require premarket approval, in two separate final orders issued July 25. Reclassification of the former takes effect July 25, while the latter's reclassification went into effect Sept. 13, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, both types of devices will still be subject to certain extra "special controls". They will not be exempt from premarket notification requirements.
The Food and Drug Administration on July 24 signed a statement of intent with its regulatory counterparts in Mexico to cooperate more closely on produce safety efforts, said FDA Deputy Commissioner for Foods Michael Taylor in a blog post. The two-page document sets out a strategy to work with Mexico to identify practices to prevent contamination during the growing, harvesting, packing, holding and transportation of fresh fruits and vegetables, as well as verification measures to ensure prevention is working, said Taylor. It also provides for the exchange of information between the two countries, enhanced collaboration on traceback activities, and the development of education and outreach materials to help companies comply with produce safety standards, he said.
On July 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of July 14-20, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: