Houston-based CCS (USA) Inc. and several of its operating subsidiaries will pay a $2.5 million civil penalty relating to operations at its Shreveport, Louisiana, industrial wastewater treatment plant, the Department of Justice, U.S. Environmental Protection Agency (EPA) and the state of Louisiana announced today. The settlement will resolve violations of the Clean Water Act, the Clean Air Act and the hazardous waste law known as RCRA

Jose Rodrigo Arechiga-Gamboa, also known as “Chino Antrax,” was formally extradited to the United States by the Netherlands today

A former senior executive of a subsidiary of Alstom SA, the French power and transportation company, pleaded guilty today for his participation in a scheme to pay bribes to foreign government officials

A Miami resident who owned a home health care company and was the administrator of another home health care company pleaded guilty today for her participation in a $74 million Medicare fraud scheme

A former project manager of a U.S. construction company working on U.S. government contracts in Afghanistan who solicited a $60,000 kickback from an Afghan subcontractor pleaded guilty today in federal court in Tucson, Arizona

The Justice Department announced today that Hewlett-Packard Co. (HP) has agreed to pay $32.5 million to resolve allegations under the False Claims Act that HP overcharged the U.S. Postal Service (USPS) for products between October 2001 and December 2010. HP is a manufacturer and vendor of information technology products and services headquartered in Palo Alto, California

On July 31, 2014, a federal jury in Los Angeles found that the former owner of a durable medical equipment (DME) supply company located in Carson, California, was guilty of health care fraud charges relating a 10-year scheme in which Medicare was fraudulently billed more than $8 million for DME that was not medically necessary

The Justice Department reached an agreement today with Travel Management Company, a private airplane charter company based in Elkhart, Indiana, resolving claims that the company engaged in citizenship status discrimination in violation of the Immigration and Nationality Act (INA).

The Department of Justice filed a settlement today with Fifth Third Mortgage Company to resolve allegations that it engaged in a pattern or practice of discrimination on the basis of disability and receipt of public assistance in violation of the Fair Housing Act (FHA) and the Equal Credit Opportunity Act (ECOA). Under the settlement, Fifth Third has agreed to maintain revised policies, conduct employee training and pay over $1.5 million to compensate victims

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division

Timothy S. Miller, 58, a co-founder of a Chesapeake, Virginia, government contracting company, pleaded guilty today to providing illegal gratuities to two public officials working for the United States Navy Military Sealift Command

The former owner of a Los Angeles medical clinic management company pleaded guilty today in connection with his role in a scheme to defraud Medicare

The former Hanover Corporation chief financial officer and a former Hanover salesman were sentenced today to serve 60 months in prison and 70 months in prison respectively, and ordered to pay $14,454,999.19 in restitution, for their roles in an $18 million Ponzi scheme. Hanover’s former chief executive officer was previously sentenced to 14 years in prison and ordered to pay $14,784,983.75 in restitution in this case

A co-owner of Professional Medical Home Health LLC was sentenced today to serve 70 months in prison and ordered to pay $6.2 million in restitution for her participation in a health care fraud scheme involving the now defunct home health care company

ExxonMobil Pipeline Company (ExxonMobil) has agreed to pay a civil penalty for an alleged violation of the Clean Water Act stemming from a 2012 crude oil spill from ExxonMobil’s “North Line” pipeline near Torbert, Louisiana, the Department of Justice and the Environmental Protection Agency (EPA) announced today. Under the consent decree lodged today in federal court, ExxonMobil will pay $1,437,120 to resolve the government’s claim

Political consultant Gregory Naylor, 66, of Philadelphia, pleaded guilty today to making false statements to federal agents and misprision of a felony in connection with his role in attempting to conceal two campaign finance-related fraud schemes

The Department of Justice announced today that it will require Tyson Foods Inc. to divest Heinold Hog Markets, its sow purchasing business, in order to proceed with its $8.5 billion acquisition of The Hillshire Brands Company. The department said that, without the required divestiture, the transaction would have combined companies that account for more than a third of sow purchases from U.S. farmers, thereby likely reducing competition for purchases of sows from farmers.

A former Iowa State Senator pleaded guilty today to concealing payments he received from a presidential campaign in exchange for switching his support and services from one candidate to another and to obstructing a subsequent investigation into his conduct.

The owner of a Florida mortgage company, seven employees of the company and two real estate developers were indicted in the Southern District of Florida in connection with an alleged $50 million mortgage fraud scheme.

The Justice Department announced today the filing of a lawsuit with the Executive Office for Immigration Review against Louisiana Crane Company LLC (Louisiana Crane), which is headquartered in Eunice, Louisiana.

The Justice Department announced today that it reached an agreement with Culinaire International, a catering and restaurant management company headquartered in Houston, Texas, resolving a claim that Culinaire engaged in citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA).

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

The owner and operator of a Miami home health care company was sentenced to 75 months in prison today for her participation in a $6.5 million Medicare fraud scheme involving the now defunct home health care company, Nestor’s Health Services Inc.

The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike.

The Department of Justice and the Corporation for National and Community Service (CNCS), which administers AmeriCorps national service programs, has awarded $1.8 million in grants to increase the effective and efficient adjudication of immigration proceedings involving certain children who have crossed the U.S. border without a parent or legal guardian.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

The general manager of a Southern California ambulance company pleaded guilty yesterday in Los Angeles to conspiracy to commit Medicare fraud, conspiracy to obstruct a Medicare audit, and making materially false statements to law enforcement officers.

A Plus Home Health Care Inc. and its owners, Tracy Nemerofsky and her father, Stephen Nemerofsky, have agreed to pay $1.65 million to the United States to settle allegations that A Plus paid spouses of referring physicians for sham marketing positions in order to induce patient referrals.

A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims

The former president and majority stockholder of a construction company was sentenced to five years in prison today following her plea of guilty to filing a false tax return and her conviction by a jury of conspiracy to defraud the United States, wire fraud, mail fraud, false statements, interstate transportation of property taken by fraud, conspiracy to obstruct justice and obstruction of justice, announced Acting Assistant Attorney General Caroline D. Ciraolo of the Justice Department’s Tax Division and U.S. Attorney Wendy J. Olson for the District of Idaho.

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.

The chief executive of a supplement company under investigation by FDA could go to prison for allegedly violating the terms of his supervised release following a criminal conviction in 2014.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

by Justin Elliott, Paul Kiel and Lydia DePillis

Through programs like the Small Business Administration’s Paycheck Protection Program and the Federal Reserve’s Main Street Lending Program, the federal government is deploying hundreds of billions of dollars in grants, loans and bond purchases to help businesses amid the coronavirus-sparked economic crisis. Each program comes with different strings, but their basic purpose is to keep workers on the payroll.

We want to know what this means for your workplace. How has your company treated its workers during the crisis? Have you or your colleagues been laid off, furloughed or otherwise affected? Have you seen money used in surprising ways? What do you think we should be reporting on?

We are the only ones reading what you submit. If you would prefer to use an encrypted app, here is what we suggest. Send questions to bailout@propublica.org.

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

Track the latest numbers on deaths in U.S. states and territories. Updated daily.

The repo rate has been reduced by 75 basis points from 5.15 percent to 4.4 percent.

The White House named three nominees to sit on a board that oversees federal employee pension funds.

The post White House appointments to impact pension fund investment decisions in China appeared first on DealStreetAsia.