Allen was the former pharmacist-in-charge of Meds IV and Rogers was the former president of Meds IV. In total, 15 defendants named in a November 2018 complaint now have been permanently enjoined from engaging in fraudulent mailings. The defendants ceased all operations as of June 2014, and are prohibited from resuming operations until FDA determines that their manufacturing practices have come into compliance with the law. The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004. Another consent decree entered in that case on March 2 barred defendants Jon Kahen, Global Voicecom, Inc., and Global Telecommunication Services Inc. from conveying recorded telephone calls, directing calls into the United States from overseas, and originating calls within the United States. Va.). According to an indictment returned last October, Xu agreed with a confidential government informant to mislabel synthetic stimulants arriving in the United States or otherwise help to hide from retailers the true nature of a proposed new dietary supplement. The money laundering was in connection with an international lottery fraud scheme involving co-conspirators in Florida and Jamaica. The information alleged that beginning in or around February 2011, Meds IV compounded its own amino acid solution, which it then mixed with other ingredients to form TPN. Sentencing hearings for Geissler, Doyle, and Patel are set for July 27, July 29, and August 10, 2020, respectively. In reality, Romeos companies sold Chinese knock-off hoodia that was imported using forged documentation. In pleading guilty, Gali admitted that from 2006 through 2011, he and his brother, Chaim Gali, devised a scheme to defraud consumers by misrepresenting the mileages of used vehicles. Press Release In some instances, a person may be entitled to file a complaint, trusting the legal system to punish the wrongdoer with prosecution, while bringing a civil lawsuit to receive compensation for the damages done by the wrongdoer. Docket Number: 18-CR-10461 (D. A company without a food facility registration cannot distribute any food products. Docket Number: 2:17-CV-6154 (E.D.N.Y.). In a complaint filed on September 20, the United States alleged that Parrish violated the Food, Drug, and Cosmetic Act by causing ready-to-eat caviar to become adulterated by being prepared, packed, or held under insanitary conditions. The injunction prohibits defendants from manufacturing and distributing unapproved drugs, and, among other measures, requires Sonar to cease manufacturing until the company implements remedial measures, including establishing a quality assurance and quality control program and retaining an expert to conduct a comprehensive evaluation of Sonars operations. In a complaint filed September 10, 2020, the United States alleged that the defendants violated the Food, Drug, and Cosmetic Act and the Produce Safety Rule by growing sprouts and preparing and holding soy products that FDA inspections showed did not comply with food safety regulations. In March 2006, B. Braun started buying saline syringes from AM2PAT, Inc. (AM2PAT), despite already being aware of problems related to AM2PAT complying with current good manufacturing practices. Peruvian Man Sentenced to 88 Months of Imprisonment for Overseeing Call Centers that Threatened and Defrauded Spanish-Speaking U.S. Consumers, United States v. Rodolfo Hermoza Victims sent money to mailboxes located in the United States and received no cash prizes. The solicitations misled recipients into believing that they would receive large sums of money or powerful talismans for payments of $50 to $55. On August 2, 2018, Karen Turner was sentenced to nine months in prison for wire fraud and money laundering in connection with two fraudulent pharmacies that Turner used to divert prescription drugs into the gray market. The remainder will be distributed among the settlement member states in alignment with terms of the agreement. Bearden, the former compliance director of Pharmakon Pharmaceuticals, Inc. (Pharmakon), of Noblesville, Indiana, pleaded guilty in November 2017 to conspiracy and nine counts of adulterating drugs. The callers claimed to be attorneys or government representatives and falsely told victims that they had failed to pay for or receive a delivery of products. judgment in a civil action. According to an indictment returned in October 2017, Zhang and two co-defendants agreed with a confidential government informant to either mislabel synthetic stimulants such as 1,4-DMAA or otherwise help to hide the true nature of a proposed dietary supplement from retailers. In 2015, drugs manufactured by the pharmacy were potentially linked to a 2015 outbreak of Staphylococcus aureus infections in Rhode Island. In addition, Valdes and Font were charged with money laundering, and Valdes was charged with making a false statement to FDA investigators during a regulatory inspection. Following a jury trial in the Southern District of Florida, Mathauda was sentenced to 200 months imprisonment. In June 2018, Canadian citizens Maria Thanos and Philip Lett pleaded guilty in the Eastern District of New York to charges of conspiracy to commit mail fraud for their roles in the operation of the same psychic mail fraud scheme. On March 18, 2004, the United States Attorney's Office for the Southern District of New York and the Section moved to intervene in A.B. The consent decree requires the defendants to establish and implement a quarantine or segregation system that ensures ready distinction between medicated and unmediated animals and that prevents defendants from selling or delivering for food slaughter any animals with illegal new animal drug residues in their edible tissues. United States v. All Articles of Other-Sonic Generic Ultrasound Transmission Gel;United States v. Pharmaceutical Innovations, Inc. Press ReleaseDocket Number: 2:14-CV-6139 (D.N.J. One of Robinsons co-conspirators, the title clerk who issued many of the fraudulent titles, was sentenced to five years of probation with 12 months of home detention in September 2016. Indian Cancer Drug Manufacturer Agrees to Plead Guilty and Pay $50 Million for Allegedly Concealing and Destroying Records in Advance of FDA Inspection. Va.). Nationally prominent civil rights attorneys Lee Merritt and Ben Crump announced Sunday that they were taking the case and promptly criticized authorities in Kansas City, Missouri, for releasing . On December 1, 2014, the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing Inc. of Los Angeles and its corporate officers, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky, to prevent the distribution of adulterated seafood products. In pleading guilty, Lledo admitted that while working for a particular clinical trial site in Miami called Unlimited Medical Research, she helped to fabricate data for a clinical trial designed to test the efficacy of two asthma treatments in a pediatric population by falsely representing that subjects were participating in the trial when, in fact, they were not participating or taking the study medication as required. If the request is granted, the fee is waived. A French businessman sued Uber for $48 million, claiming that a flaw in the ride-sharing company's app played a role in the dissolution of his marriage. Consent Decree Filed in Enforcement Action Against New Jersey Drug Manufacturer and Owner United States v. Acino Products, LLC, and Ravi Deshpande The order, part of the United States long-running racketeering lawsuit against the cigarette companies, also requires them to attach the same statements to cigarette packages for two weeks at a time, for a total of twelve weeks over two years. Ltd., an India-based company. Defendant Sentenced for Conspiring to Defraud the FDA and for Distribution of Over- and Under-Potent Compounded DrugsUnited States v. Paul Elmer and Caprice BeardenPress Release The complaint also alleged that the company failed to manufacture its medicated feeds in conformity with current good manufacturing practices. This is called "remote access Under the Federal Food, Drug, and Cosmetic Act, the failure to follow cGMP renders drugs manufactured under such conditions adulterated. On November 4, 2016, Sheikh Waseem Ul Haq was sentenced to time served, and three years supervised release, for his role in a long-running conspiracy to ship pharmaceuticals from Pakistan and the United Kingdom (UK) to customers in the United States. Jury Finds All Defendants Liable in Utah Telemarketing CaseUnited States v. Feature Films for Families, Inc., et al.Docket Number: 2:12-CV-0811 (D. Utah). Epsilon further admitted that over the course of nearly a decade, the company knowingly sold 30 million American consumers data to clients engaged in fraud. Ind.). (Joel) Frantzman, to prevent the distribution of adulterated seafood products. Olympus pleaded guilty to three misdemeanor counts and Yabe to one misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act by failing to file the required reports with the U.S. Food & Drug Administration. United States v. Christopher Reyes, Case No. ACell further admitted that it did not notify doctors who already had purchased or used contaminated MicroMatrix about the removal. According to the complaint, Parrish failed to ensure the temperature of ready-to-eat caviar remained at a level low enough to control Clostridium botulinum growth and toxin formation, which can cause botulism. Docket Number: 1:16-CR-20821 (S.D. According to the complaint, victims who received these solicitations sent payments through the U.S. and international mail systems to defendants Trends Service in Kommunikatie, B.V. (Trends), and Kommunikatie Service Buitenland, B.V. (KSB), both owned and operated by defendant Erik Dekker. The order further requires the defendants to have the independent laboratory test their cheese products for the presence of Listeria, E. coli, and other bacteria. The complaint alleged that the defendants were not complying with the FDAs current good manufacturing practice regulations and were, accordingly, misbranding the dietary supplements they manufacture and sell. In denying MediNaturas motion, the court held that the company could not establish a likelihood of success on the merits of those claims without first asking the court to reconsider its dismissal of them. The Fourth Circuit recently held that it did, joining two other appellate courts and worsening an existent circuit split. TPN is liquid nutrition administered intravenously to patients who cannot or should not receive their nutrition through eating. On July 5, 2016, the district court entered a consent decree of permanent injunction against BEK Catering, LLC d/b/a Floppers Foods, LLC, and its co-owners Billy D. Stembridge, Jr. and Kyle Huxen, to stop them from violating the Food, Drug, and Cosmetic Act (FDCA). Mass.). Docket Numbers: 1:19-cr-20658 (S.D. Docket Number: 1:20-cv-493 (W.D. Mich.). Va.)). Both defendants were also sentenced to one year of supervised release following their imprisonment and a $5,000 fine. Many homeowners lost their homes to foreclosure after hiring the firms. Both companies, along with five individuals, pleaded guilty last year. Court Dismisses Challenge to FDAs Emergency Use Authorization for Hydroxychloroquine Related to COVID-19 Assn of Am. Peruvian Man Sentenced to 90 Months Imprisonment for Overseeing Call Centers that Threatened and Defrauded American Consumers, United States v. Francesco Guerra On December 21, 2022, the U.S Attorney's Office for the Eastern District of Michigan executed a settlement agreement with Julie B. Griffiths Law Office, a small law family practice in Flint, Michigan, under Title III of the ADA regarding failing to provide appropriate auxiliary aids and services to ensure effective communication for an individual who is deaf and uses American Sign Language. Ill.). 1, 2018, filed a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley, Jr., to stop the manufacturing and distribution of adulterated drugs. It does not hear criminal cases. In January 2014, Ul Haq entered guilty pleas to all 48 counts of the indictment, which charged him with conspiracy to import and distribute Schedule II, III, and IV controlled substances, conspiracy to defraud the United States and its agencies and introduce into interstate commerce misbranded drugs, conspiracy to commit international money laundering, and numerous substantive offenses of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act. On June 1, 2020, U.S. District Judge David Counts issued a temporary restraining order under the anti-fraud injunction statute (18 U.S.C. In pleading guilty, Bearden admitted that she and her co-defendant, Paul J. Elmer, Pharmakons former president, lied during multiple FDA inspections about test results concerning under- and over-potent compounded sterile drugs manufactured by Pharmakon and distributed to hospitals nationwide. The FDA had specifically refused Acclarents request to clear the Stratus for marketing as a drug delivery device without further submissions to support that use. In civil cases in the U.S., the person suing is known as the plaintiff while the person being sued is called the defendant. Scilabs is a contract manufacturer of dietary supplements distributed under the brand name All Pro Science, including Complete Immune + capsules and various flavored powders called Complete, Recovery and Precharge. Fla.). 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