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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Other Modified FDA Import Alerts for the Week of Dec. 17-23

December 26, 2012 by Brian Feito|FDA

During the week of Dec. 17-23, 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:

New and Revised FDA Import Alerts for Dec. 19-20

December 21, 2012 by Brian Feito|FDA

On Dec. 19-20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Now Accepting Electronic Submission of Laboratory Analyses, Plans to Automate Reviews

December 21, 2012 by Tim Warren|FDA

The Food and Drug Administration will now accept electronic versions of private laboratory reports, said CBP in a CSMS message. Electronic submission is preferred, though the FDA will still accept hard copies. The FDA intends to automate its analytical reports review processes, said the CSMS message. Once that's accomplished, FDA will be able to process private laboratory analytical reports submitted via electronic means in less time than is needed to process private laboratory analytical reports submitted in hard copy forms, it said. To avoid potential delays, private laboratory analytical reports should be submitted electronically, said CBP.

FDA Enforcement Report on Recalls & Field Corrections for Dec. 19

December 20, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Dec. 19 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Dec. 18

December 19, 2012 by Brian Feito|FDA

On Dec. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Threatens Device Importer with Seizure, Civil Penalties

December 19, 2012 by Brian Feito|FDA

The Food and Drug Administration threatened device importer and distributor Prime Herbs Corp. with seizure, injunction, and civil monetary penalties for a host of violations that caused FDA to declare the company’s infrared heating lamp adulterated and misbranded. The warning letter, dated Dec. 10, alleges violations of current good manufacturing practice regulations, Medical Device Reporting violations, unapproved marketing, and failure to provide adequate directions for use. FDA said the violations could also affect the awarding of government contracts, as well as premarket approval for related products.

New and Revised FDA Import Alerts for Dec. 17

December 18, 2012 by Brian Feito|FDA

On Dec. 17 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. 10-16

December 18, 2012 by Brian Feito|FDA

During the week of Dec. 10-16, 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:

New and Revised FDA Import Alerts for Dec. 14

December 17, 2012 by Brian Feito|FDA

On Dec. 14 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. 13

December 14, 2012 by Brian Feito|FDA

On Dec. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: