On Aug. 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 sent warning letters to two medical device manufacturers after FDA inspections that revealed non-compliance with the current good manufacturing practice requirements of the Quality System regulation. In a warning letter dated July 26, FDA warned Royal King Infant Products of Thailand that its teething rings face detention without physical examination unless and/or until it corrects violations including, among other things, verification and corrective action procedures. FDA also sent a warning letter dated Aug. 1 to Compumedics Germany for similar reasons, but did not say the company’s offending imaging diagnostic systems are subject to detention without physical examination.
Italian cheese manufacturer Ciresa Formaggi, Snc. faces detention without physical examination of its products if it doesn’t correct alleged unsanitary conditions at its plant, said the Food and Drug Administration in a warning letter. In January, FDA inspected the plant and found that Ciresa’s Taleggio cheese was stored on splintered and rough surfaces. The cheese was stored on pieces of cloth, but the edges of the cheese came into direct contact with the surface below. In its response to the investigation, Ciresa said it had placed bigger pieces of cloth underneath, but the FDA said the cloth is porous and still does not allow for adequate cleaning as required by the Current Good Manufacturing Practice (CGMP) regulation for food.
The Food and Drug Administration is inviting tobacco product importers, manufacturers, and distributors, among others, to participate in its Tobacco Product Manufacturing Facility Visits program. The program is intended to provide FDA staff with the opportunity to observe tobacco product manufacturing operations and learn about manufacturing practices and processes as they implement the tobacco provisions of the Food, Drug and Cosmetic Act. Parties interested in participating should send requests by Oct. 15.
The Food and Drug Administration warned three tobacco product vendors that they face civil penalties and/or refusal of their products at the border if they continue to offer flavored and “modified risk” cigarettes for sale in the U.S. In warning letters sent to Karl Bergman (here) (pennycigarettes.com and saveonfags.com) and Dumitru Chitoroaga (here) (juicynewt.com), both of Moldova, the FDA said the companies sold cigarettes branded as apple, cherry, and mint flavored, which are either adulterated if actually flavored or misbranded if not. Additionally, both companies sold cigarettes described as “light” or “ultra-light” cigarettes, which as “modified risk” tobacco products are prohibited for sale in the U.S. A similar warning letter sent to cigs360.com of Australia (here) also alleged sale of “modified risk” cigarettes in the U.S.
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.
The Food and Drug Administration announced it will hold the Fall 2012 Regulatory Education for Industry Conference for small businesses Sept. 19-20 in Washington, DC. At the conference, held by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), attendees will be able to network, engage with FDA experts, and learn more about FDA’s regulatory requirements for drugs and medical devices. Advance registration is required, but is free and includes training materials only, FDA said. Registration and more information on the conference available here.
The Food and Drug Administration announced the availability of a draft guidance entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” as provided by Section 102 of the Food Safety Modernization Act (FSMA). FSMA amended Section 415 of the Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.
On Aug. 13 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. 6-12, 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 of: