The Food and Drug Administration threatened to place Korean fish processor Yangpo Foods Co.’s products on detention without physical examination in a warning letter dated Sept. 5. According to the letter, FDA will refuse entry of the products unless Yangpo corrects its Hazard Analysis and Critical Control Point (HACCP) plan. Yangpo had responded in May to allegations stemming from an FDA on-site investigation, but FDA deemed Yangpo’s revised HACCP plans for canned mackerel and mackerel-pike to be deficient.
On Sept. 10 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 Sept. 3-9, 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 Sept. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 6 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 Sept. 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Sept. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 4 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 Aug. 27 - Sept. 2, 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:
The Food and Drug Administration sent warning letters to two persons that offer cigarette products for sale to consumers in the U.S., alleging the products are adulterated. In a letter sent to Madeleine Rausis of Switzerland on Aug. 23 (here), FDA alleged the websites http://www.smoke-cigs.com and http://www.tobacco4you.com offer cigarettes for sale in the U.S. that are marketed as “light,” “mild,” or “low,” and so are adulterated “modified risk tobacco products.” The websites also offered cigarettes that FDA considers to be adulterated because they contain an artificial or natural flavor that is a characterizing flavor of the products. FDA also sent a warning letter to Andy Winata of Indonesia Aug. 20 (here), affiliated with the websites http://www.kretekindonesia.com, http://www.inacigarette.com, and http://www.inacigar.com, alleging the offering for sale in the U.S. of “modified tobacco risk products” and clove cigarettes, which FDA considers to be flavored.