R. Dale Frazier, 57, of Flora Vista, N.M., pleaded guilty today in U.S. District Court in Albuquerque, N.M., to a federal civil rights charge in connection with the unlawful assault and beating of Dovovan Tanner with a flashlight.

The Justice Department has filed a lawsuit against the city of San Jacinto, Calif., alleging violations of the Fair Housing Act and the Americans with Disabilities Act based on its treatment of group homes for persons with disabilities. This lawsuit is part of the Justice Department’s continuing effort to enforce civil rights laws that require states and municipalities to end discrimination against, and unnecessary segregation of, persons with disabilities.

Mohammad Jafar Nikbakht, aka Freydoon Nikbakht, was sentenced Friday to 15 months in prison for evading his individual income taxes.

A certified public accountant (CPA) and purported outside auditor for Provident Capital Indemnity Ltd. (PCI) was sentenced today in Richmond, Va., to 54 months in prison for his role in an approximately half-billion-dollar fraud scheme that affected more than 3,500 victims throughout the United States and abroad.

Sanofi-Aventis U.S. Inc. and Sanofi-Aventis U.S. LLC, subsidiaries of international drug manufacturer Sanofi (collectively, Sanofi US), have agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act by giving physicians free units of Hyalgan, a knee injection, in violation of the Anti-Kickback Statute, to induce them to purchase and prescribe the product. The settlement also resolves allegations that Sanofi US submitted false average sales price (ASP) reports for Hyalgan that failed to account for free units distributed contingent on Hyalgan purchases. The government alleges that the false ASP reports, which were used to set reimbursement rates, caused government programs to pay inflated amounts for Hyalgan and a competing product.

Victory Pharma Inc., a specialty pharmaceutical company headquartered in San Diego, has agreed to pay $11,420,743 to resolve federal civil and criminal liability arising from its marketing of the pharmaceutical products Naprelan, Xodol, Fexmid and Dolgic, the Justice Department announced today. Under the agreement announced today, Victory entered into a deferred prosecution agreement and paid a criminal forfeiture of $1.4 million to resolve federal Ant-Kickback Statute allegations, and paid $9,938,310 to resolve False Claims Act allegations.

A federal court has permanently barred Pete Escalante Gutierrez and Jeanette Gutierrez from preparing federal tax returns for others.

A former co-owner of a U.S. civilian contractor company was sentenced today in San Antonio to serve 30 months in prison for falsifying official documents in connection with Iraq reconstruction government contracts.

Today the United States filed a civil action against ATP Oil &s Bureau of Safety and Environmental Enforcement (BSEE) and the U.S. Environmental Protection Agency (EPA). The complaint addresses the defendants’ alleged unlawful discharges of oil and unpermitted chemical dispersants from the defendants’ floating oil and gas production platform, the ATP Innovator, into the Gulf of Mexico.

A former San Francisco investment banker and his college friend both pleaded guilty today for their roles in an insider trading scheme involving two impending corporate mergers.

A California woman pleaded guilty to illegally feeding killer whales in the wild this Tuesday in federal court in San Jose, Calif.

Ash Grove Cement Company has agreed to pay a $2.5 million penalty and invest approximately $30 million in pollution control technology at its nine Portland cement manufacturing plants to resolve alleged violations of the Clean Air Act.

The Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today that the San Antonio Water System (SAWS) has agreed to make significant upgrades to reduce overflows from its sewer system and pay a $2.6 million civil penalty to resolve Clean Water Act (CWA) violations stemming from illegal discharges of raw sewage. The state of Texas is a co-plaintiff in this case and will receive half of the civil penalty.

Two individuals, Donald Torriero and Julius DeSimone, were sentenced in federal court in Utica, N.Y., for illegally dumping thousands of tons of asbestos-contaminated construction debris on a 28-acre piece of property on the Mohawk River in upstate New York, the Justice Department announced.

The Justice Department announced today that the United States has filed a civil injunction suit against Michael I. Turner, of San Diego to stop him from preparing federal tax returns.

Attorney General Eric Holder announced today that the Justice Department’s Bureau of Justice Assistance (BJA) will provide $2.5 million in funding to the Connecticut State Police, the Newtown, Conn., Police Department and their partner agencies that provided assistance in response to the shootings at Sandy Hook Elementary School last year.

Jonathan Deck, 59, of Norwood, N.J., was sentenced today in federal court in Utica, N.Y., to 15 months in prison for conspiring to commit wire fraud in connection with the illegal dumping of thousands of tons of asbestos-contaminated construction debris on a 28-acre piece of property on the Mohawk River in upstate New York, the Justice Department announced.

A Vietnamese national has been indicted in the District of New Hampshire for allegedly participating in an international scheme to steal and sell hundreds of thousands of Americans’ personally identifiable information (PII) through various underground websites that he operated.

Attorney General Eric Holder today endorsed the reauthorization of the Second Chance Act, bipartisan legislation introduced by Senators Patrick Leahy and Rob Portman and its companion legislation by Representatives Danny Davis and F. James Sensenbrenner, Jr. that provides resources and support to people reintegrating into their communities after being incarcerated.

The Justice Department today reached an agreement with Kim Hoang Coffee and Fast Food, a restaurant in San Francisco, resolving claims that the company violated the anti-discrimination provision of the Immigration and Nationality Act (INA).

U.S. Attorney General Eric Holder on Thursday urged Congress to pass the bipartisan Smarter Sentencing Act, introduced by Senators Dick Durbin and Mike Lee.

Sanborn Map Company Inc. has agreed to pay $2.1 million to the U.S. government to resolve allegations that it submitted false claims in connection with U. S. Army Corps of Engineers contracts.

Two Florida men were sentenced today to serve 84 months in prison for defrauding thousands of homeowners in a $4 million nationwide home loan modification scheme.

Following a four-week trial, a federal jury today convicted two real estate investors for conspiring to rig bids at public real estate foreclosure auctions held in San Joaquin County, Calif. One of the investors was also convicted of obstruction of justice for destroying evidence related to the crimes

That's why we are all gathered here this morning. Under the leadership of Attorney General Eric Holder, the U.S. Department of Justice has used a variety of tools to respond when law enforcement misconduct is uncovered. Those include everything from technical assistance provided by our Office of Justice Programs and our COPS Office to full-fledged enforcement actions by our Civil Rights Division and U.S. Attorney's Offices around the country, and everything in between.

After a bench trial handled by the Department of Justice, the U.S. District Court for the Eastern District of New York has entered an injunction against New York City Fish Inc., Maxim Kutsyk, Pavel Roytkov, Leonid Staroseletesky and Steven Koyfman under the federal Food, Drug and Cosmetic Act (FDCA).

A Maryland man was sentenced today to serve one year and a day in prison for defrauding thousands of homeowners in a $4 million nationwide home loan modification scheme.

Li Fangwei, who is more commonly known by his alias “Karl Lee,” is charged with violating the International Emergency Economic Powers Act (IEEPA) by using United States-based financial institutions to engage in millions of dollars of U.S. dollar transactions in violation of economic sanctions that prohibited such financial transactions.

A federal judge in California has permanently barred Michael I. Turner, of San Diego, from preparing federal tax returns for others, the Justice Department announced today.

The Justice Department today announced a settlement with the city of San Jacinto, California, that resolves a lawsuit alleging disability discrimination filed in the U.S. District Court for the Central District of California. Under the settlement, San Jacinto has changed its laws to comply with the Fair Housing Act (FHA) and the Americans with Disabilities Act (ADA).

According to court documents submitted today, BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, agreed to enter a guilty plea to conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) by processing billions of dollars of transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions

BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, pleaded guilty today before U.S. District Judge Lorna G. Schofield in the Southern District of New York to a one-count information charging the bank with conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA), for its role in processing billions of dollars of U.S. dollar transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions from 2004 through 2012

The U.S. Environmental Protection Agency today announced a Clean Water Act settlement requiring the East Bay Municipal Utility District (EBMUD) and seven East Bay communities to conduct extensive system repairs aimed at eliminating millions of gallons of sewage discharges into San Francisco Bay. Under today’s agreement, EBMUD and the communities will assess and upgrade their 1,500 mile-long sewer system infrastructure over a 21-year period

A Russian national indicted for hacking into point of sale systems at retailers throughout the United States and operating websites that distributed credit card data of thousands of credit card holders appeared today for arraignment in U.S. federal court, announced U.S. Attorney Jenny A. Durkan of the Western District of Washington and Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division

The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

    WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 1, 2018

Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
 
Dear Mr. Kringle:

The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.

This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1.    Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).

Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.



Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.

2.    Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).

Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.

Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall.  Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were.

3.    Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).

Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.

Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.

4.    Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)).

While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???

5.    Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)).

Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)

Conclusion

Violations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.

Sincerely,
/S/
Holly Bush
Division Director/OPQO Division I
North Pole District Office

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

###

 

Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies.

The company receives approval for MenQuadfi to prevent meningococcal disease.

Sanofiâs insulin aspart biosimilar receives positive opinion from the EMAâs CHMP.

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.

California college students will get emergency CARES grants

Apr 28, 2020

Stephen Walt writes that even though Bernie Sanders is out of the presidential race, the time has come for many of the policies that he promoted: Universal Healthcare; Democratic Socialism; Income Redistribution; and Foreign Policy.