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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 Submits Proposal for Accreditation of VQIP 3rd-Party Auditors to OMB for Approval
November 26, 2012 by Brian Feito|FDA

The Food and Drug Administration submitted its proposed rule on “Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes” for approval by the Office of Management and Budget Nov. 24. The rule would set out regulations on FDA’s use of accreditation bodies to approve third-party auditors. The third-party auditors would conduct certifications foreign establishments for use in FDA’s coming Voluntary Qualified Importer Program (VQIP), pursuant to the Food Safety Modernization Act.

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.