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 May Refuse Chinese Manuf. Haotian's Drugs for No Registration

September 5, 2012 by Brian Feito|FDA

The Food and Drug Administration posted a warning letter Sept. 4 threatening refusal of admission for Chinese drug manufacturer Zhucheng Haotian Pharm Co., Ltd.’s products because the company has not met registration requirements. According to the warning letter, dated June 11, Haotian did not register its establishment in 2011 or 2012, but has continued to manufacturer, prepare, propagate, compound, or process drugs that were being imported or offered for import into the U.S. during this time. FDA sent a warning letter to the company in October 2011, but said Haotian did not take any action in response to the letter. As a result, FDA may refuse admission of Haotian’s drugs, it said.

FDA Warns 4 Device Manufacturers for CGMP Deviations, No Reporting Procedures

September 5, 2012 by Brian Feito|FDA

The Food and Drug Administration posted warning letters Sept. 4 it sent to device manufacturers in Tunisia, France and China threatening denial of premarket approval applications, and another warning letter to a device manufacturer in Taiwan for a lack of Medical Device Reporting.

New and Revised FDA Import Alerts for Aug. 31

September 4, 2012 by Brian Feito|FDA

On Aug. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Distributors Announce Recall of Mexican Daniella Brand Mangoes for Salmonella

September 4, 2012 by Brian Feito|FDA

Distributors have announced a spate of recalls of mangoes and mango products due to salmonella contamination of Daniella brand mangoes imported from Mexico. Produce distributor Splendid Products announced a recall on Aug. 29, which prompted World Foods, Pacific Coast Fruit Company, Stop & Shop, Winn-Dixie, Ready Pac, and F&S Produce to issue recalls for products containing mangoes distributed by Splendid. Spokane Produce, Taylor Farms, Real Foods, Charlie’s, and BI-LO also issued recalls for Daniella brand mangoes. According to several of the recalls, the mangoes can be identified by a Daniella brand sticker. The mangoes have been linked to a number of recent cases of salmonellosis in Canada, and may be linked to cases in California and perhaps other states, said Splendid’s release.

New and Revised FDA Import Alerts for Aug. 30

August 31, 2012 by Brian Feito|FDA

On Aug. 30 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 Aug. 29

August 30, 2012 by Brian Feito|FDA

On Aug. 29 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 Aug. 29

August 30, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 29 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 Aug. 28

August 29, 2012 by Brian Feito|FDA

On Aug. 28 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 Aug. 27

August 28, 2012 by Brian Feito|FDA

On Aug. 27 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 Aug. 20-26

August 28, 2012 by Brian Feito|FDA

During the week of Aug. 20-26, 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: