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Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged today with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators.



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Cincinnati Packaged-Ice Manufacturer Sentenced to Pay $9 Million for Its Role in a Customer and Territory Allocation Conspiracy

The Home City Ice Company pleaded guilty in 2008 to conspiring to suppress and eliminate competition by allocating packaged-ice customers and territories in the Detroit metropolitan area and southeastern Michigan.



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Medical Device Manufacturer Guidant Pleads Guilty for Not Reporting Defibrillator Safety Problems to FDA

Guidant LLC pleaded guilty today in St. Paul, Minn., before U.S. District Court Judge Donovan W. Frank to criminal violations of the Federal Food, Drug and Cosmetic Act.



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Georgia Food Equipment Hardware Manufacturer and Its Former President Agree to Plead Guilty to Customer Allocation Conspiracy

A New York corporation, whose principal place of business is Newnan, Ga., and its former president have agreed to plead guilty to conspiring to allocate customers for the sale of food service equipment hardware, including walk-in refrigeration equipment.



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Heart Device Manufacturer in Minnesota and Hospitals in Ohio & Kentucky to Pay Nearly $4 Million to Resolve Fraud Allegations

St. Jude Medical Inc., a heart device manufacturer; Parma Community General Hospital; and Norton Healthcare have paid the United States $3,898,300 to resolve false claim allegations that St. Jude paid illegal kickbacks to two hospitals to secure heart-device business.



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Billboard Manufacturer Pleads Guilty to Hazardous Waste Related Charges

Selective Structures L.L.C. pleaded guilty and was sentenced today for illegally storing hazardous waste at its facility in Athens, Tenn.



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Justice Department Files a Lawsuit Alleging Employment Discrimination by Georgia Rug Manufacturer and Seller

The Department filed a lawsuit against Garland Sales Inc., a rug manufacturer and seller located in Dalton, Ga., alleging it engaged in a pattern or practice of discrimination by imposing unnecessary and discriminatory hurdles to employment for work authorized individuals.



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Mcwane Inc. Agrees to Resolve Environmental Violations at Manufacturing Facilities in 14 States

McWane Inc., a national cast iron pipe manufacturer headquartered in Birmingham, Ala., has agreed to pay $4 million to resolve more than 400 violations of federal and state environmental laws.



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United States Takes Action to Reduce Hazards from Fertilizer Manufacturing Plant in Florida

CF Industries Inc. has agreed to spend approximately $12 million to implement facility-wide operational changes to reduce and properly manage hazardous wastes generated at its Plant City, Fla., phosphoric acid and ammoniated fertilizer manufacturing facility.



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Georgia Manufacturer of Food Service Equipment Hardware Pays $3.3 Million Fine for Role in Customer Allocation Conspiracy

A New York corporation, whose principal place of business is Newnan, Ga., was sentenced to pay a $3.3 million criminal fine for conspiring to allocate customers in the food service equipment hardware market, including walk-in refrigeration equipment.



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Cheese Manufacturer Sorrento Lactalis to Pay U.S. $315,000 for Exceeding Discharge Levels into Idaho’s Mason Creek

Cheese manufacturer Sorrento Lactalis Inc. will pay the United States a $315,000 penalty for excess discharges in violation of its wastewater permit levels, according to an agreement between the company.



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United States Sues Marine Engine Manufacturer and Shipbuilder Under Clean Air Act

The United States filed a civil complaint today against Coltec Industries Inc., a subsidiary of EnPro Industries Inc., and the National Steel and Shipbuilding Company, a subsidiary of General Dynamics Corp.



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GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant

SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility.



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Former President of New Jersey Manufacturer and Distributor of Food Service Equipment Hardware Charged with Conspiracy to Allocate Customers

An Atlanta grand jury returned an indictment today against the former president and chief executive officer of a Lakewood, N.J.-based manufacturer and distributor of food service equipment hardware, for conspiring to allocate customers for the sale of commercial and institutional food service equipment hardware.



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Pharmaceutical Manufacturers to Pay $421.2 Million to Settle False Claims Act Cases

Abbott Laboratories Inc., B. Braun Medical Inc. and Roxane Laboratories Inc. n/k/a Boehringer Ingelheim Roxane Inc. and affiliated entities have agreed to pay $421 million to settle False Claims Act allegations, the Justice Department announced today.



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Assistant Attorney General Tony West Speaks at Press Conference Announcing Major Settlements with Pharmaceutical Manufacturers

"Over the last two years, the Justice Department—in close collaboration with the Department of Health and Human Services—has made cracking down on health care fraud a top priority. Today, we announce the latest results of those efforts."




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Pharmaceutical Manufacturer to Pay $280 Million to Settle False Claims Act Case

Dey Inc., Dey Pharma L.P. (formerly known as Dey, L.P.) and Dey L.P. Inc. have agreed to pay $280 million to settle False Claims Act allegations, the Department of Justice announced today.



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Medical Device Manufacturer Guidant Sentenced for Failure to Report Defibrillator Safety Problems to FDA

Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was formally convicted and sentenced today in St. Paul, Minn., for criminal violations relating to its interactions with the Food and Drug Administration (FDA).



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Cement Manufacturer to Pay $1.4 Million and Install Emission Controls to Resolve Clean Air Act Violations at Ohio Plant

CEMEX Inc., one of the largest producers of Portland cement in the United States, will spend an estimated $2 million on pollution controls that will reduce harmful emissions of nitrogen oxides (NOx) and sulfur dioxide (SO2), pollutants that can lead to childhood asthma, acid rain, smog and impaired visibility in national parks. Under a settlement to resolve Clean Air Act violations at its cement plant in Fairborn, Ohio, CEMEX will also pay a $1.4 million penalty, the U.S. Department of Justice and the Environmental Protection Agency (EPA) announced today.



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New York Battery Manufacturer to Pay $2.7 Million for False Pricing Information Provided to U.S. Army

Newark, N.Y.-based Ultralife Corporation, formerly known as Ultralife Batteries Inc., has agreed to pay $2.7 million to resolve allegations that the battery manufacturer violated the False Claims Act.



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U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million

The U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA. pleaded guilty today to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct.



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Executive of Taiwan Aftermarket Auto Lights Manufacturer Arrested and Indicted for Participation in Price-Fixing Conspiracy

An executive of a Taiwan manufacturer of aftermarket auto lights was indicted today for participating in a global conspiracy to fix the prices of aftermarket auto lights.



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Justice Department Settles Allegations of Immigration-Related Employment Discrimination Against Kinro Manufacturing Inc.

The Justice Department today reached a settlement agreement with Kinro Manufacturing Inc. in Goshen, Ind., resolving allegations that the company engaged in a pattern or practice of discrimination against work-authorized non-citizens in the employment eligibility verification process.



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Florida Manufacturer of Skin Products Agrees to Consent Decree to Resolve Allegations of FDCA Violations

The complaint and consent decree were filed today in accordance with an agreement with the defendants resolving numerous violations of the Food, Drug and Cosmetic Act.



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Taiwan Aftermarket Auto Lights Manufacturer and Its Chairman Indicted for Participation in Price-Fixing Conspiracy

A federal grand jury in San Francisco returned a superseding indictment yesterday against a Taiwan aftermarket auto lights manufacturer, its U.S.-based subsidiary distributor and its chairman for participating in an international conspiracy to fix the prices of aftermarket auto lights.



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California Building Materials Manufacturer Agrees to Pay $1.4 Million to Settle Clean Air Act Violations

The Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today that CalPortland Company (CPC), a major producer of Portland cement and building materials in the United States, has agreed to pay a $1.425 million penalty to resolve alleged violations of the Clean Air Act at its cement plant in Mojave, Calif.



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Justice Department Settles Allegations of Citizenship Status Discrimination and Retaliation Against Georgia Rug Manufacturer

The Justice Department announced a settlement today with Garland Sales Inc., a Georgia rug manufacturer, resolving allegations that it engaged in discrimination by imposing unnecessary documentary requirements on individuals of Hispanic origin when establishing their eligibility to work in the United States, and that it retaliated against a worker for protesting his discriminatory treatment.



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Former Chairman of Taiwan Aftermarket Auto Lights Manufacturer Agrees to Plead Guilty in Price-Fixing Conspiracy

The former chairman of a Taiwan aftermarket auto lights manufacturer has agreed to plead guilty for his participation in an international conspiracy to fix the prices of aftermarket auto lights.



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Shipbuilder and Ship Engine Manufacturer Agree to Pay Civil Penalty and Perform Environmental Project to Resolve Clean Air Act Violations

Coltec Industries Inc. and National Steel and Shipbuilding Company have agreed to pay a civil penalty of $280,000 and spend approximately $500,000 on an environmental project to resolve alleged violations of the Clean Air Act and EPA’s marine diesel engine air rules.



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Department of Justice Seizes More Than $1.5 Million in Proceeds from the Online Sale of Counterfeit Sports Apparel Manufactured in China

The investigation also resulted in the seizure of three domain names used in the sale of counterfeit sports apparel.



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Texas-based Medical Device Manufacturer Pays U.S. $34 Million to Settle False Claims Act Allegations

Orthofix Inc., a Texas-based manufacturer of medical devices, has agreed to pay the United States $34,234,263 to settle allegations under the civil False Claims Act relating to the company’s sale of bone growth stimulator devices, the Justice Department announced today. The company has also agreed to plead guilty to a felony of obstruction of a federal audit, and to pay a $7,765,737 criminal fine.



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Japanese Automobile Parts Manufacturer Agrees to Plead Guilty to Price Fixing on Parts Installed in US Cars

Nagoka, Japan-based Nippon Seiki Co. Ltd. has agreed to plead guilty and to pay a $1 million criminal fine for its role in a conspiracy to fix prices of instrument panel clusters, commonly known as meters, installed in cars sold in the United States and elsewhere.



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Taiwan Auto Lights Manufacturer Executive Pleads Guilty in Price-Fixing Conspiracy

The vice chairman and second-highest ranking officer of a Taiwan aftermarket auto lights manufacturer pleaded guilty today for his participation in an international conspiracy to fix the prices of aftermarket auto lights.



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New Jersey Glass Manufacturer to Install State-of-the-Art Emissions Controls to Resolve Violations of the Clean Air Act

Under a settlement announced today by the Department of Justice and the U.S. Environmental Protection Agency (EPA), Durand Glass Manufacturing Company Inc. has agreed to install emissions controls on its three glass furnaces that will reduce more than 173 tons of nitrogen oxides (NOx) and 23 tons of particulate matter (PM) per year.



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Taiwan Auto Lights Manufacturer and Its California Distributor Plead Guilty in Price-Fixing Conspiracy

A Taiwan aftermarket auto lights manufacturer and its U.S. distributor pleaded guilty to an indictment charging them with participating in a seven-year, international conspiracy to fix the prices of aftermarket auto lights, and were sentenced today in U.S. District Court for the Northern District of California.



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Japanese Automobile Parts Manufacturer Agrees to Plead Guilty to Price Fixing and Obstruction of Justice

Nagoya, Japan-based Tokai Rika Co. Ltd., has agreed to plead guilty and to pay a $17.7 million criminal fine for its role in a conspiracy to fix prices of heater control panels (HCPs) installed in cars sold in the United States and elsewhere.



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Justice Department Reaches Settlement with New York Manufacturer to Resolve Immigration-Related Unfair Employment Practices

The Justice Department announced today that it reached a settlement agreement with R-Tronics LLC, a company based in Rome, N.Y., which manufactures custom and prototype cables, wire harnesses and electro-mechanical assemblies. The agreement resolves allegations that the company violated the anti-discrimination provision of the Immigration and Nationality Act (INA) by limiting its hiring practices to U.S. citizens.



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Ohio-Based Wheelchair Manufacturer Agrees to Consent Decree to Resolve Allegations of Food, Drug and Cosmetic Act Violations

The Justice Department, at the request of the Food and Drug Administration (FDA), today filed a complaint and a proposed consent decree in the U.S. District Court for the Northern District of Ohio against Invacare Corp., Gerald B. Blouch and Ronald J. Clines.



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Automotive Electronics Manufacturer Fined $500,000 for Selling Illegal Devices Resulting in Tons of Excess Particulate Matter Emissions

In a settlement with the United States on behalf of the U.S. Environmental Protection Agency, automotive electronics manufacturer Edge Products LLC (Edge) has agreed to pay a $500,000 civil penalty for manufacturing and selling electronic devices that allowed owners of model year 2007 and later diesel pickup trucks to remove emission controls from their vehicles.



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Permanent Injunction Entered Against Michigan-Based Manufacturer of Soy Products

U.S. District Judge David M. Lawson, of the Eastern District of Michigan, entered a consent decree of permanent injunction against Ann Arbor, Michigan-based Green Hope LLC, dba Rosewood Products, and its president, Phil G. Ye.



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District Court Enters Permanent Injunction Against Ohio-Based Drug Manufacturer and Company’s Senior Executives

U.S. District Court Judge Lesley Wells entered a consent decree of permanent injunction against Ben Venue Laboratories Inc., a Bedford, Ohio-based drug manufacturer.



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Cement Manufacturer Agrees to Reduce Harmful Air Emissions at Colorado Plant

The U.S. Department of Justice (DOJ) and the U.S. Environmental Protection Agency (EPA) announced today that CEMEX, Inc., the owner and operator of a Portland cement manufacturing facility in Lyons, Colo., has agreed to operate advanced pollution controls on its kiln and pay a $1 million civil penalty to resolve alleged violations of the Clean Air Act (CAA).



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New York Woman Sentenced for Scheme to Defraud Consumer Product Manufacturers

A New York woman was sentenced to 19 months in prison today for her role in a scheme to defraud consumer product manufacturers.



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Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty today to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India.



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Justice Department Sues South Dakota Drug Manufacturer for Improperly Producing Sterile Eye Drops

The government filed suit in the U.S. District Court for South Dakota against Dakota Laboratories LLC and its owner, Charles L. Voellinger, Sr., to block them from violating the Food, Drug and Cosmetic Act (FDCA) in connection with their alleged violations of Current Good Manufacturing Practices (CGMP).



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Nine Automobile Parts Manufacturers and Two Executives Agree to Plead Guilty to Fixing Prices on Automobile Parts Sold to U.S. Car Manufacturers and Installed in U.S. Cars

Nine Japan-based companies and two executives have agreed to plead guilty and to pay a total of more than $740 million in criminal fines for their roles in separate conspiracies to fix the prices of more than 30 different products sold to U.S. car manufacturers and installed in cars sold in the United States and elsewhere, the Department of Justice announced today. The department said that price-fixed automobile parts were sold to Chrysler, Ford and General Motors, as well as to the U.S. subsidiaries of Honda, Mazda, Mitsubishi, Nissan, Toyota and Fuji Heavy Industries–more commonly known by its brand name, Subaru.



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Ohio-Based Basco Manufacturing Co. to Pay $1.1 Million for Allegedly Falsifying Customs Documents to Evade Import Duties on Chinese Products

Ohio-based Basco Manufacturing Co. (Basco) has agreed to pay $1.1 million to resolve allegations that it violated the False Claims Act by making false customs declarations to avoid paying duties on products imported from a Chinese manufacturer, and that it has filed a complaint against four other companies and two individuals based on similar allegations.



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Medical Device Manufacturer Charged With Major Securities Fraud Scheme

ArthroCare Corporation, a medical device manufacturer based in Austin, Texas, and that trades on the NASDAQ stock exchange, has agreed to pay a $30 million monetary penalty to resolve charges that senior executives at the company engaged in a securities fraud scheme that resulted in more than $400 million in shareholder losses.



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Koito Manufacturing Co. Ltd. Agrees to Plead Guilty to Price Fixing on Automobile Parts Installed in U.S. Cars

Koito Manufacturing Co. Ltd., a Tokyo-based company, has agreed to plead guilty and to pay a total of $56.6 million in criminal fines for its roles in separate price-fixing conspiracies involving automobile lighting fixtures and lamp ballasts installed in cars sold in the United States and elsewhere.



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Washington-Based Medical Device Manufacturer to Pay up to $5.25 Million to Settle Allegations of Causing False Billing of Federal Health Care Programs

Medical device manufacturer EndoGastric Solutions Inc. has agreed to pay the government up to $5.25 million to resolve allegations that it violated the False Claims Act by misleading health care providers about how to bill federal health care programs for a procedure using a device manufactured by the company and by paying kickbacks.



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