The Food and Drug Administration released a draft guidance for its staff on food facility registration, including Food Safety Modernization Act provisions for registration renewal and suspension of registration. Policies recommended by the draft guidance include holding food imports from facilities with lapsed or suspended registrations at the port, and notifying the FDA Division of Food Defense Targeting (formerly the Prior Notice Center) so it can target food imports from the offending facilities. If finalized, the draft guidance will “represent FDA’s current thinking on this topic.”
The International Trade Commission is publishing notices in the April 3 Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will appear in another ITT article):
The International Trade Administration published notices in the April 3 Federal Register on the following AD/CV duty proceedings (any notices that announce changes to AD/CV duty rates, scope, affected firms, or effective dates will be detailed in another ITT article):
Consumer Product Safety Commission announced the following voluntary recalls April 2 (country of manufacture in parentheses):
On April 2 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 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 2 the Foreign Agricultural Service issued the following GAIN reports:
The Animal and Plant Health Inspection Service announced changes April 2 to Plant Protection and Quarantine (PPQ) electronic manuals. While some changes are minor, other changes may affect the admissibility of the plant products, including fruits, vegetables, and flowers.