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FDA to Hold Meeting on Revised FSMA Proposed Rules
October 22, 2014 |FDA

The Food and Drug Administration will hold a public meeting on Nov. 13 in College Park, Maryland, to discuss changes announced in September to four proposed rules required by the Food Safety Modernization Act. In four supplemental proposed rules published in late September, FDA amended proposed regulations it issued in 2013 on the Foreign Supplier Verification Program, preventative controls for human and animal food, and produce safety (see 14091917 and 14092901). At the meeting, FDA officials will hear public comments, explain the rulemaking process, and answer questions on the revised proposals. Seating is limited, so meeting attendees should register by Nov. 7. The meeting will also be available via webcast.

Other Modified FDA Import Alerts for the Week of Oct. 13-19
October 21, 2014 |FDA

During the week of Oct. 13-19, 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:

FDA Finalizes Guidance on Examples of Illegal Impediments to Drug Facility Inspectors
October 21, 2014 |FDA

The Food and Drug Administration finalized a guidance document outlining circumstances that constitute delaying, denying, limiting, or refusing a drug facility inspection. Under the Food and Drug Administration Safety Improvement Act (FDASIA) of 2012, FDA can seek criminal penalties for delaying, limiting, or refusing drug facility inspections, and can deem the associated product adulterated in such instances.

FDA Refusing Imports From Two Chinese Pharma Companies
October 20, 2014 |FDA

The Food and Drug Administration told two Chinese drug facilities that it plans to refuse admission to their pharmaceutical products, in two warning letters sent in late September. FDA says it found violations of current good manufacturing practice (CGMP) regulations for pharmaceuticals at a China Resources Sanjiu (999) Medical and Pharmaceutical Co., Ltd. located in Shenzhen (here). It also said the facility is unregistered because the company changed locations without amending its registration. As a result, FDA is already refusing shipments of pharmaceuticals from the facility. In a separate letter, FDA notified Beijing Shunxin Meihua Bio-technical Co., Ltd. that it has been placed on three import alerts because it refused or limited an inspection by FDA officials (here). Additionally, from the documents it was able to review, the agency said it found the company is being supplied with crude heparin by another company that is already on an import alert for the pharmaceutical product.