December 2012

FDA Extends Until January 31 for Food Facilities to Re-Register

Below are the latest and greatest updates regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA’s extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration – meaning they can NOT import into the U.S. FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Re-Inspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted […]

By Jennifer Diaz|2022-07-08T15:53:43-04:00December 18, 2012|Bioterrorism Act, Enforcement, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

New Center of Excellence & Expertise to Arrive in Miami 2013!

U.S. Customs and Border Protection (CBP) Deputy Commissioner David V. Aguilar announced at the East Coast Trade Symposium the expansion of the Centers of Excellence and Expertise (Centers), which will create six new Centers in 2013 for the Agriculture & Prepared Products; Apparel, Footwear & Textiles; Base Metals; Consumer Products & Mass Merchandising; Industrial & Manufacturing Materials; and Machinery industries. CEE’s are “virtual “one-stop shops” that provide centralized processing for importers that volunteer to participate. TheCenters are also already a source of information for the entire trading community. Centers are virtual organizations, managed from a strategic location, that link CBP trade personnel by industry to authoritatively facilitate trade.”

CBP’s goal is to eventually cover the full range of imported goods. For now, the Centers to be established in FY 2013 are:

Agriculture & Prepared Products: Miami
Apparel, Footwear & Textiles: San Francisco
Base Metals: Chicago
Consumer Products & Mass Merchandising: Atlanta
Industrial & Manufacturing Materials: Buffalo
Machinery: Laredo

These virtual centers will provide one-stop processing to lower the Trade’s cost of business, provide greater consistency and predictability and enhance CBP enforcement efforts. The Centers represent CBP’s expanded focus on “Trade in the 21st Century,” transforming customs procedures to align with modern business. The Centers will also serve as resources to the broader trade community and to CBP’s U.S. government partners. The current Centers are Electronics in Long Beach; Pharmaceuticals, Health & Chemicals in New York City; Automotive & Aerospace in Detroit; and Petroleum, Natural Gas & Minerals in Houston.

Resources to learn more […]

By Jennifer Diaz|2022-07-08T15:53:52-04:00December 17, 2012|CEE, U.S. Customs and Border Protection (CBP)|1 Comment

An International Business Masters: Success in a Borderless Economy

Rapidly advancing technologies offer businesses the chance to enjoy an international presence. In line with the increasing opportunities for businesses to conduct their affairs on a global scale, there is a growing demand for expertly qualified individuals who understand the intricacies of international business practices.

It is unlikely that a bachelors degree on its own will suffice to launch an executive level career in international trade. Although there are certain elements of business studied at an undergraduate level that will put a student in good stead for a future career in the field of international trade, the majority of recruiters will require applicants to be educated at a graduate level. A Masters in International Business offers a focused route to becoming the type of applicant that business leaders want to hire.

MBA/MIB courses in this area will typically include study of the core subjects involved in any masters program. Each college and university is different, but core subjects generally include such topics as financial reporting and analysis, the legalities of operating a business, and managerial economics. Following completion of requisite courses, students will move on to specialize in the various aspects of corporate management at an international level. These may include such subjects as international trade laws, global logistics, and foreign market investments. It is also likely that students will be expected to achieve competency in one or more foreign languages. Internships at companies based overseas may be offered.

Where to Study a Masters in International Business

Many business schools offer electives in the […]