On Feb. 5 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 three device manufacturers in Germany, Switzerland, and Korea, detailing violations of current good manufacturing practice regulations by each facility. FSSB Chirurgische Nadeln of Germany (here), and Tecval Medical of Switzerland (here), were each warned by FDA that premarket approval applications and requests for certificate to foreign governments may be denied until their violations are corrected. Given the “serious nature” of violations by Sometech Incorporated of Korea (here), FDA will keep that company’s products on import alert, it said.
The Food and Drug Administration posted a Dec. 12 warning letter it sent to Novo Nordisk, after finding violations of current good manufacturing practice regulations for the company’s drug products at its Bagsvaerd, Denmark, facility. FDA said it may withhold approval of new applications of supplement listings for the company, and could even deny admission to Novo Nordisk’s drugs manufactured at the offending facility. Novo Nordisk had 15 working days to respond to the letter, which have already elapsed.
The Food and Drug Administration scheduled meetings to discuss its recently proposed produce safety and preventative controls rules in Chicago on March 11-12, and in Portland, Ore., March 27-28. FDA will also ask for comments from stakeholders on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules, it said. FDA already announced a similar meeting in Washington, D.C. Feb. 28 -- March 1.
On Feb. 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 Jan. 28 - Feb. 3, 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 Feb. 1 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 warned Italian device manufacturer Spes Medica Srl that its Battipaglia, Italy, facility isn’t conforming to current good manufacturing practice requirements. Requests for premarket approvals and government certificates related to the violative devices, electromyography needles, may be denied unless the violations are corrected, FDA said.
The Food and Drug Administration may refuse imports of Taiwanese pharmaceutical company Beanne Chemical Co.’s products, it said in a warning letter. An FDA inspection found numerous current good manufacturing practice regulations, and discovered that the company was not meeting registration and listing requirements, the letter said. FDA gave the facility 15 days to either respond with corrective actions or notify FDA it no longer produces the violative products.
The Food and Drug Administration finalized its new criteria for ordering administrative detention of food for human or animal consumption, adopting a May 4, 2011, interim final rule without change. Under the criteria adopted by FDA, the agency can order an administrative detention if there is “reason to believe that an article of food is adulterated or misbranded.” Although the criteria have been in effect since July 3, 2011, this final rule is effective Feb. 5.