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EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding. 

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FDA Warns Chinese & Japanese Device Companies for CGMP Violations
November 21, 2012 by Brian Feito|FDA

The Food and Drug Administration warned Chinese and Japanese device manufacturers that their products do not conform to current good manufacturing practice (CGMP) requirements of the Quality System regulation, in two warning letters dated Nov. 13. Premarket approval applications for related devices, and Requests for Certificates to Foreign Governments, will not be approved until Chinese company A&D Electronics (Shenzhen) (here) and Japanese company Osachi (here) correct the violations, FDA said. In its warning letter to Osachi, FDA also said the company’s devices are misbranded because it has no written Medical Device Reporting procedures.

FDA May Place UK, Denmark Device Firms on Import Alert, Conduct Reinspections for CGMP Violations
November 21, 2012 by Brian Feito|FDA

The Food and Drug Administration said in two warning letters that it may place devices manufactured by United Kingdom-based Integra Neurosciences (here) and Denmark-based Tonica Elektronik (here) on import alert after inspections revealed deviations from current good manufacturing requirements at both companies’ facilities. Integra also offered for sale a non-FDA approved device in a catalog distributed in the U.S., FDA said in its warning letter to the company. Both facilities will be subject to reinspection to ensure compliance, FDA said.

FDA Moves Up Proposed UDI Deadline for Implantable, Life-Sustaining Devices
November 16, 2012 by Brian Feito|FDA

The Food and Drug Administration amended its July 10 proposed rule establishing a unique device identification system by moving up the effective date for devices that are “implantable, life-supporting, and live sustaining” to no later than two years from the finalization of the rule. The changes are pursuant to the Food and Drug Administration and Innovation Act (FDASIA), signed into law on July 9, which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) in ways that require modification of the implementation timeline, FDA said.