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 posted a warning letter Sept. 4 threatening refusal of admission for Chinese drug manufacturer Zhucheng Haotian Pharm Co., Ltd.’s products because the company has not met registration requirements. According to the warning letter, dated June 11, Haotian did not register its establishment in 2011 or 2012, but has continued to manufacturer, prepare, propagate, compound, or process drugs that were being imported or offered for import into the U.S. during this time. FDA sent a warning letter to the company in October 2011, but said Haotian did not take any action in response to the letter. As a result, FDA may refuse admission of Haotian’s drugs, it said.
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.
The Food and Drug Administration posted warning letters Sept. 4 it sent to device manufacturers in Tunisia, France and China threatening denial of premarket approval applications, and another warning letter to a device manufacturer in Taiwan for a lack of Medical Device Reporting.
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:
Distributors have announced a spate of recalls of mangoes and mango products due to salmonella contamination of Daniella brand mangoes imported from Mexico. Produce distributor Splendid Products announced a recall on Aug. 29, which prompted World Foods, Pacific Coast Fruit Company, Stop & Shop, Winn-Dixie, Ready Pac, and F&S Produce to issue recalls for products containing mangoes distributed by Splendid. Spokane Produce, Taylor Farms, Real Foods, Charlie’s, and BI-LO also issued recalls for Daniella brand mangoes. According to several of the recalls, the mangoes can be identified by a Daniella brand sticker. The mangoes have been linked to a number of recent cases of salmonellosis in Canada, and may be linked to cases in California and perhaps other states, said Splendid’s release.
On Aug. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 30 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 Aug. 29 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Aug. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: