The Food and Drug Administration issued its weekly Enforcement Report for April 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On April 15 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 April 7-13, 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 April 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 posted a new Compliance Policy Guide for its staff on enforcement criteria for canned ackee, frozen ackee, and other ackee products. Ackee naturally contains a toxin called hypoglycin A, and the fruit has to be processed in certain ways to minimize health risks. The guide (here) tells FDA staff that ackee is considered to be adulterated if it contains hypoglycin A at levels above 100 ppm. In such cases, FDA staff are to refuse entries of imported ackee.
On April 11 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 April 9 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 reclassifying stair-climbing wheelchairs as Class II devices that do not require premarket approval, in a final rule that takes effect April 14. 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, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Stair-climbing wheelchairs will not be exempt from premarket notification requirements.
The Food and Drug Administration is approving use of ionizing radiation for control of food-borne pathogens in crustaceans. Effective April 12, FDA will allow irradiation up to a maximum dose of 6 kiloGray to treat chilled or frozen raw, cooked, or partially cooked crustaceans, and dried crustaceans. The National Fisheries Institute had originally requested the change to FDA’s food additive regulations in 2001. Objections or requests for hearings are due May 14.
The Food and Drug Administration recently warned three exporters in South Korea, India, and Thailand that it may begin refusing entry to their fish products because of hazard analysis and critical control point (HACCP) violations. In three separate warning letters, the agency told Seorak Clean Food of South Korea (here), Britto Seafoods of India (here), and Royal Foods of Thailand (here) that their fish products may be placed on import alert if the violations are not corrected. The agency also said that, because the violations are related to food safety, it may assess reinspection fees on each company’s U.S. agent to cover the costs of having to go back to each company’s facility and make sure they are in compliance.