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 Finalizes Guidance on Food Product Categories on Facility Registrations

October 23, 2012 by Brian Feito|FDA

The Food and Drug Administration formally announced the availability of its final guidance on the “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” in a notice set for publication in the Oct. 24 Federal Register. The guidance was issued Oct. 19, in conjunction with the beginning of food facility registration renewal. The guidance includes FDA’s determination that information about food product categories in food facility registrations is necessary for a quick, accurate, and focused response to a food safety related issue or incident, an actual or potential bioterrorist incident, or other food-related emergency, and identifies the additional food product categories included as mandatory fields in food facility registrations, as follows:

New and Revised FDA Import Alerts for Oct. 19-21

October 22, 2012 by Brian Feito|FDA

On Oct. 19-21 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 Oct. 18

October 19, 2012 by Brian Feito|FDA

On Oct. 18 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 Oct. 17

October 18, 2012 by Brian Feito|FDA

On Oct. 17 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 Oct. 17

October 18, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Oct. 17 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

FDA Sends Warning Letters to 6 Foreign Device Firms for CGMP, Reporting Violations

October 18, 2012 by Brian Feito|FDA

The Food and Drug Administration sent out warning letters to six foreign device manufacturing facilities, according to recent postings on the FDA website. Xiantao Rayxin Medical Products Co. Ltd. of China (here), DMC Medical Technology & Manufacturing Co., Ltd. of China (here), and EPS Biotechnology Corp. of Taiwan (here) were each sent warning letters for deviations from current good manufacturing practice (CGMP) requirements of FDA’s quality system regulations. Accordingly, FDA said the offending products were adulterated. Warning letters sent to Nissei Precision Instruments (Suzhou) Co., Ltd. of China (here), Copious International, Inc. of Taiwan (here), and SMT-Schilling Metalltechnik GmbH of Germany (here) not only detailed CGMP violations by each firm, but also said the firms failed to meet medical device reporting requirements because they failed or refused to provide required information to FDA. As a result, certain products manufactured by Nissei, Copious, and SMT-Schilling were found to be both adulterated and misbranded by FDA.

New and Revised FDA Import Alerts for Oct. 16

October 17, 2012 by Brian Feito|FDA

On Oct. 16 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 Oct. 15

October 16, 2012 by Brian Feito|FDA

On Oct. 15 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 Oct. 12-14

October 15, 2012 by Brian Feito|FDA

On Oct. 12-14 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 Oct. 11

October 12, 2012 by Brian Feito|FDA

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