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 Enforcement Report on Recalls & Field Corrections for May 22

May 23, 2013 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for May 22 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

FDA Considers Blocking Imports from German API & Drug Facility

May 22, 2013 by Brian Feito|FDA

The Food and Drug Administration is considering refusing admission of imports of active pharmaceutical ingredients (APIs) and finished pharmaceuticals from Boehringer-Ingelheim Pharma’s Ingelheim am Rhein, Germany facility. According to an FDA warning letter, an agency inspection found serious violations of current good manufacturing practice requirements for both types of products at the facility.

New and Revised FDA Import Alerts for May 20

May 21, 2013 by Brian Feito|FDA

On May 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Other Modified FDA Import Alerts for the Week of May 14-20

May 21, 2013 by Brian Feito|FDA

During the week of May 14-20, 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 to Block Imports of Rubimed's Biofeedback Devices for PMA, CGMP, MDR Violations

May 21, 2013 by Brian Feito|FDA

The Food and Drug Administration is taking steps to refuse admission of Rubimed’s REBA Feedback Devices, after discovering that the Switzerland-based company does not have a valid approved premarket approval application for the device, the agency said in a warning letter dated May 6. The device will be put on detention without physical examination for the violations, which also include deviations from current good manufacturing practices and failure to comply with Medical Device Reporting requirements, FDA said.

New and Revised FDA Import Alerts for May 17-19

May 20, 2013 by Brian Feito|FDA

On May 17-19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for May 16

May 17, 2013 by Brian Feito|FDA

On May 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

External Lab Analysis Can Now be Submitted in ITACS, Says FDA

May 17, 2013 by Tim Warren|FDA

The Food and Drug Administration added a new document type for "External Lab Analytical Package" in the Import Trade Auxiliary Communication Systems (ITACS), it said in a CSMS message. The FDA said it prefers to receive private lab results in electronic formats and can process electronically submitted results faster than hard copies.

New and Revised FDA Import Alerts for May 15

May 16, 2013 by Brian Feito|FDA

On May 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for May 15

May 16, 2013 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for May 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.