Kathryn Keneally, the Assistant Attorney General for the Tax Division of the Department of Justice, Preet Bharara, the U.S. Attorney for the Southern District of New York and Richard Weber, the Chief of the Internal Revenue Service, Criminal Investigation (IRS-CI), announced today that Liechtensteinische Landesbank AG, a bank based in Vaduz, Liechtenstein (LLB-Vaduz), has agreed to pay more than $23.8 million to the United States and entered into a non-prosecution agreement (NPA) with the U.S. Attorney’s Office for the Southern District of New York.

The Justice Department announced today the unsealing of a superseding indictment returned by a federal grand jury in Sacramento, Calif., charging Teresa Marie Marty, Charles Tingler and Victoria Tingler, all of Placerville, Calif., with conspiracy to defraud the United States and filing multi-million dollar liens against government officials.

Two financial investors who purchased municipal tax liens pleaded guilty today for their roles in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of those tax liens, the Department of Justice announced.

The Justice Department filed a settlement agreement and order today that resolved allegations that Chevy Chase Bank F.S.B. engaged in a pattern or practice of discrimination against qualified African-American and Hispanic borrowers in its home mortgage lending from 2006 through 2009.

The Justice Department announced today that it has filed a lawsuit against the manager and owner of the Linden House Apartments in Cleveland for refusing to rent apartments to families with children in violation of the federal Fair Housing Act.

David Kalai and Nadav Kalai face additional charges after a federal grand jury in the Central District of California returned a second superseding indictment yesterday.

The Justice Department today filed a lawsuit against the owner and operators of a Fremont, Calif., apartment complex, alleging that they had discriminated against families with children in violation of the Fair Housing Act by prohibiting children from playing in the common grassy areas of the complex.

Keith Johnson, 46, and his wife, Angela Johnson, 44, of Maryville, Tenn., pleaded guilty today to their roles in a $9.7 million procurement fraud scheme.

The Justice Department, the Department of Housing and Urban Development (HUD) and the City of Joliet, Ill., have settled housing discrimination litigation that will preserve affordable housing for low-income residents in the southwest Chicago suburb for at least the next 20 years, the U.S. Attorney’s Office for the Northern District of Illinois and the Civil Rights Division announced today.

Robert Eldon Robertson and his wife Esther Lynne Robertson of Manteca, Calif., were indicted on charges of filing two false claims for federal tax refunds, filing liens against the former Internal Revenue Service (IRS) commissioner and impeding the administration of federal tax laws, the Justice Department and IRS announced today.

A federal grand jury in Newark, N.J., returned an indictment against six investors for their roles in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of tax liens.

The Justice Department filed a lawsuit today against the homeowner’s association, management company and property manager of a Minnetonka, Minn., condominium complex, alleging that they discriminated against families with children in violation of the Fair Housing Act.

Several California companies and individuals that formerly supplied beef to the National School Lunch Program have agreed to settle allegations of inhumane handling of cattle, circumventing appropriate inspection of nonambulatory disabled (“downer”) cattle and false representations regarding their eligibility to process beef.

The Justice Department today filed a lawsuit against the owner and manager of rental apartments in Jaffrey, N.H., for violating the Fair Housing Act by discriminating against families with children.

Edwin Stigile, formerly a Lieutenant at Roxbury Correctional Institution (RCI) in Hagerstown, Md., and two former RCI Correctional Officers, Tyson Hinckle and Reginald Martin, each pleaded guilty to an offense arising out of the assault of an inmate on Mar. 9, 2008.

Russell Burroughs, a resident of Montgomery, Ala., was indicted on 33 counts of filing false tax returns, Assistant Attorney General Kathryn Keneally of the Justice Department's Tax Division and U.S. Attorney George L. Beck Jr. for the Middle District of Alabama announced today.

The Departments of Veterans Affairs, Defense, Education and Justice, along with the Consumer Financial Protection Bureau and the Federal Trade Commission announced today the launch of a new online complaint system designed to collect feedback from veterans, service members and their families who are experiencing problems with educational institutions receiving funding from Federal military and veterans educational benefits programs, including benefits programs provided by the Post-9/11 GI Bill and the DoD Military Tuition Assistance Program.

The Justice Department filed a lawsuit today against the owner and those responsible for the management of a 126-space mobile home park in Effingham, Ill., for violating the Fair Housing Act by discriminating against African-Americans and families with children.

Monajem Hakimijoo, of Beverly Hills, Calif., pleaded guilty on Feb. 13, 2014, in the U.S. District Court for the Central District of California to filing a false federal income tax return for tax year 2007, the Justice Department and Internal Revenue Service (IRS) announced today.

The Barrio Azteca Lieutenant who ordered the murders of a U.S. Consulate employee, her husband and the husband of another U.S. Consulate employee was found guilty by a jury on all counts charged.

The Justice Department announced today that it has reached an agreement in principle with the city of New York and intervening plaintiffs to settle an employment discrimination lawsuit involving the New York City Fire Department.

The government has intervened in a False Claims Act lawsuit against Orbit Medical Inc. and Jake Kilgore alleging that Orbit Medical’s sales representatives boosted power wheelchair and accessory sales by altering and forging physician prescriptions and supporting documentation.

Francis E. Chandler III was sentenced to serve 37 months in prison and ordered to pay $3,066,629 in restitution for filing a false claim for tax refund and false retaliatory liens against four federal government officials.

Arturo Gallegos Castrellon, aka “Benny,” “Farmero,” “51,” “Guero,” “Pecas,” “Tury,” and “86,” 35, of Chihuahua, Mexico, the Barrio Azteca Lieutenant who ordered the March 2010 murders of a U.S. Consulate employee, her husband and the husband of another U.S. Consulate employee, was sentenced today to serve life in prison.

A former New York-based tax liens company executive pleaded guilty today for his role in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of tax liens.

The Department of Justice today announced the federal government’s first lawsuit filed against owners and servicers of student loans for violating the rights of servicemembers eligible for benefits and protections under the Servicemembers Civil Relief Act (SCRA).

Evgeniy Bogachev and the members of his criminal network devised and implemented the kind of cyber crimes that you might not believe if you saw them in a science fiction movie. By secretly implanting viruses on computers around the world, they built a network of infected machines – or “bots” – that they could infiltrate, spy on, and even control, from anywhere they wished.

Edwin Stigile III, formerly a lieutenant at the Roxbury Correctional Institution (RCI) in Hagerstown, Maryland, was sentenced today by U.S. District Court Judge James K. Bredar to serve 36 months in prison for obstruction of justice in connection with his involvement in a series of assaults against an inmate, Kenneth Davis, at RCI

Josh Jambon, 52, a resident of Grand Isle, Louisiana, pleaded guilty today in front of U.S. District Judge Susie Morgan to two counts of federal civil rights violations, announced Acting Assistant Attorney General Jocelyn Samuels for the Justice Department’s Civil Rights Division and U.S. Attorney Kenneth Allen Polite Jr. for the Eastern District of Louisiana

"The computers of American citizens and businesses are, as we speak, under attack by individual hackers and organized criminal groups using state-of-the-art techniques seemingly drawn straight from a science fiction movie," said Assistant Attorney General Caldwell

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn

Tyree Davis Sr., 42, of Flossmoor, Illinois, pleaded guilty to two counts of obstruction of justice and two counts of filing false retaliatory liens against government officials, the Justice Department announced today

A federal jury in Omaha, Nebraska, found Donna Marie Kozak guilty on Friday of conspiracy to file and filing false liens against two U.S. District Court judges, the U.S. Attorney for the District of Nebraska, two Assistant U.S. Attorneys and an Internal Revenue Service (IRS) special agent, the Justice Department announced

A Beverly Hills, California man was sentenced today in the U.S. District Court for the Central District of California to serve six months in prison and one year of home confinement for filing a false federal income tax return for tax year 2007, the Justice Department and Internal Revenue Service (IRS) announced

A federal jury in Omaha, Nebraska, found a Pelham, Georgia, man guilty late yesterday of seven counts of conspiracy to file and filing false liens against two U.S. District Court judges, the U.S. Attorney for the District of Nebraska, two Assistant U.S. Attorneys and an Internal Revenue Service special agent.

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.

The Justice Department announced today that under its settlements with five of the nation’s largest mortgage servicers, 952 service members and their co-borrowers are eligible to receive over $123 million for non-judicial foreclosures that violated the Servicemembers Civil Relief Act (SCRA)

Ministers address developments in the global economy and take action to safeguard the region’s growth.

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

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A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

by Yeganeh Torbati

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned.

To read the whole article click on the headline

Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

To read the whole article click on the headline

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]

The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues.

The GMP Starter Kit aims to help guide brands through current Good Manufacturing Practices (cGMP) regulations and FDA compliance for nutritional and dietary supplement brands.

California college students will get emergency CARES grants

The "Plandemic" video was the latest breakout hit from the coronavirus conspiracy theory industry. Social media companies are scrambling to ban it from their platforms.

By Anne K. Walsh —

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has made it onto CDP's Water Security A List and Supplier Engagement Leader Board. The A listing is for the company's sustainable water management practices and disclosure of information on these activities, and the selection to the leader board is for the company's leadership in engaging with its suppliers around the world to reduce carbon emissions and combat global warming.