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:
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.
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 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 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.
On Jan. 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 Jan. 30 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 will hold a public meeting Feb. 28 in Washington, D.C. to discuss its proposed produce safety and hazard analysis and risk-based preventative controls rules. At the meetings, FDA will hear oral stakeholder and public comments on the proposed rules, and inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules. On-site registration will be available, but FDA is encouraging attendees to pre-register by Feb. 20. Commenters will each have three minutes to speak. Requests to speak at the public meeting are due by Feb. 8. Requests to present, as well as advance registration, are available here.
On Jan. 29 the Food and Drug Administration posted new and revised versions of the following Import Alert on the detention without physical examination of: