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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New and Revised FDA Import Alerts for Dec. 11

December 12, 2012 by Brian Feito|FDA

On Dec. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Warns Danish Device Manufacturer for MDR, CGMP Violations

December 12, 2012 by Brian Feito|FDA

The Food and Drug Administration sent a warning letter dated Nov. 19 to MedArt A/S, a Danish medical device manufacturer, detailing violations of medical device reporting regulations and current good manufacturing practices. FDA ordered the firm to respond within 15 business days of receipt. The warning letter did not specify any consequences for failure to comply.

New and Revised FDA Import Alerts for Dec. 10

December 11, 2012 by Brian Feito|FDA

On Dec. 10 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 Dec. 3-9

December 11, 2012 by Brian Feito|FDA

During the week of Dec. 3-9, 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 Issues December Interstate Certified Shellfish Shippers List

December 11, 2012 by Brian Feito|FDA

The Food and Drug Administration (FDA) issued the December Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.

New and Revised FDA Import Alerts for Dec. 7

December 10, 2012 by Brian Feito|FDA

On Dec. 7 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 Dec. 6

December 7, 2012 by Brian Feito|FDA

On Dec. 6 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 Dec. 5

December 6, 2012 by Brian Feito|FDA

On Dec. 5 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 Dec. 5

December 6, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Dec. 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

FDA Warns Chinese, UK Device Manufacturers for CGMP Violations

December 5, 2012 by Brian Feito|FDA

The Food and Drug Administration sent warning letters to device manufacturers in the United Kingdom (here) and China (here), threatening withholding of approval for Class III devices related to the violations. FDA cited CASMED International of the UK, and Shanghai Ruike Sports Goods of China, for violations of the current good manufacturing practices of the Quality System regulation. Shanghai Ruike was also cited for failure to comply with Medical Device Reporting regulations.