The Food and Drug Administration issued the April Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration sent a warning letter March 15 to South Korean device manufacturer Feel-Tech, alleging violations of current good manufacturing practices at the company’s Cheonan-si facility. Among the violations were insufficient corrective action plans to prevent recurrence of needles dislodging from its syringe barrels. The syringes had been the subject of two separate recalls due to the problem. FDA ordered the company to respond within 15 days of receipt of the letter, warning that premarket approval applications from the company may be denied until the violations are corrected.
The Food and Drug Administration will continue to refuse imports of active pharmaceutical ingredients (API) manufactured by Japanese company Asada Milling Co., Ltd.’s facility in Kanra, Japan, it said in a warning letter. The products at the facility were already subject to import alert for current good manufacturing practice violations. The company failed to correct the problems, FDA said.
On April 1 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 March 25-31, 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:
On March 29-31 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 extending until July 3 the period for submitting comments on the results of its product tracing pilot. The Institute of Food Technologists submitted its report in early March on the pilot, which included companies involved in supply chains for frozen and dry Kung Pao chicken and fresh tomatoes (see 13030418). According to the report, the pilot participants appeared to have in place many of the tools necessary to capture and submit data required for product tracing, although inconsistencies in the data often delayed interpretation by IFT.
The Food and Drug Administration posted a new guidance on user fees and refunds for Premarket Approval Applications (PMAs) and device Biologics License Applications (BLAs). The guidance identifies the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that don’t have a user fee, FDA said. It also identifies circumstances where the fee may be refunded. The guidance is (here).
The Food and Drug Administration amended its regulations on biologics license applications, and BLA amendments and supplements, to show a change of address for the Center for Devices and Radiological Health effective April 2. The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
The Food and Drug Administration is revising statements required in labeling for over-the-counter nicotine replacement therapy products, it said in a notice set for publication in the April 2 Federal Register. The agency said recent evidence shows that statements on concurrent use of nicotine replacement products with other products that contain nicotine, including cigarettes, as well as a statement on use of nicotine replacement therapy products beyond the intended period, are no longer necessary to ensure safe and effective use. FDA said it is encouraging submission of supplemental new drug applications to modify these statements. See FDA’s notice for new recommended language.