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Intuitive intelligence data management application that enables collaborative teams of analysts to capture, control and analyze multi-source data in security-rich workgroup environments. Learn more about IBM i2 iBase. Learn, refresh and develop your i2 technical skills to help in fraud and financial crime investigations. Learn more. Connect now. Get answers. Read more. Security Intelligence analysis I2 Fight fraud and financial crime Use an intelligence analysis tool to tackle complex investigations and detect sophisticated fraud and financial crime across your enterprise Start your demo. Case studies Solutions Resources.
What does a fraud and financial crime investigation entail? IBM i2 cyber threat hunter prevents banking fraud. The decrees against Hill and Woods were entered on February 26, , and June 27, , respectively. The decree against Lyman was filed on July 12, , and is subject to court approval. Braun Medical Inc.
Braun Press Release. On May 18, , drug and medical device company B. Braun pre-filled saline flush syringes in In March , B. Braun saline syringes through a new radiation sterilization process. Before B. Two months after B. Braun recalled all of the syringes because the radiation sterilization process caused dangerous white particles to develop in the saline inside the syringes.
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However, B. Braun resumed buying syringes from AM2PAT without going to the new facility, and despite receiving new information showing that AM2PAT moved manufacturing equipment into its new facility without validating that the equipment worked as expected. Less than a month after B. Braun saline syringes contaminated with Serratia marcescens bacteria. After these infections, all of B.
The resolution with B. Braun included a non-prosecution agreement in which B. Braun admitted that it distributed B.
Braun syringes that were adulterated under the Food Drug and Cosmetic Act. Under the terms of the agreement, B. Braun will increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis. Acino manufactures hydrocortisone acetate 25 mg suppositories, which it labels and sells as prescription drugs.
Because Acino has never submitted an application for FDA approval of the drugs, they have never been found to be safe and effective. Further, because they are prescription drugs, their labels by definition cannot bear adequate directions for use by a layperson.
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In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA. Once entered by the court, the consent decree will require Acino to cease all manufacture and distribution of the unapproved and misbranded suppositories, and to destroy any such suppositories already in existence.
Pharmaceutical Innovations Inc. Pharmaceutical Innovations, Inc. On October 2, , the United States filed a complaint for a permanent injunction against Pharmaceutical Innovations Inc. The company makes gels that hospitals and other caregivers use to take ultrasound scans. The complaint alleges that the defendants are in violation of current good manufacturing practice and quality-system requirements, and are marketing medical devices without either clearance or approval.
In February , a Michigan hospital traced infections among 16 surgical patients to a specific gel made by Pharmaceutical Innovations. FDA testing on samples of the gel tested positive for bacterial contamination. The relevant lots of that particular gel were seized in a seizure lawsuit the United States filed in ; the company is actively contesting that lawsuit. In a third lawsuit, the company sued the FDA in early for denying it an export certificate attesting that it is in full compliance with the FDCA.
On June 21, , David Allen and William Rogers were sentenced to 12 months and 10 months in prison, respectively, in connection with the distribution of adulterated drugs.
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TPN is liquid nutrition administered intravenously to patients who cannot or should not receive their nutrition through eating. The information alleged that beginning in or around February , Meds IV compounded its own amino acid solution, which it then mixed with other ingredients to form TPN. As charged in the information, amino acid used in compounding the TPN was adulterated in that it was contaminated with Serratia marcescens S.
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These infections can cause serious medical complications, including death, because S. According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used. As alleged in the information, between March 5 and 15, , nine patients at various Birmingham-area hospitals who developed bloodstream infections caused by S.
As alleged in the information, while a number of the patients who died had underlying conditions which may have contributed to their deaths, medical records of some patients suggest that the S. On February 19, , Joseph Dallal was sentenced to serve 33 months in prison in connection with two separate prescription drug diversion schemes. Dallal was previously charged in the District of Puerto Rico and the Southern District of Ohio for selling illegally-sourced prescription drugs in connection with two distinct drug diversion schemes.
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Dallal procured the drugs from multiple illegal and unlicensed sources and sold them to co-conspirators without the required pedigree document stating where Dallal had purchased the drugs. The cases were consolidated for plea and sentencing in Puerto Rico. On December 5, , Dallal pled guilty to two counts of conspiracy to commit mail and wire fraud. On February 3, , Catherine Nix was sentenced to 15 months imprisonment, and on October 6, , Wada Hollis and Thomas Giddens were also sentenced to 15 months imprisonment for their roles in in a prescription drug smuggling ring.
All three defendants previously pled guilty to charges of conspiracy to smuggle imitation, unapproved, and misbranded prescription drugs from China. The defendants conspired to smuggle at least 43 known shipments, totaling approximately , pills, from China to Texas. Customs and Border Protection authorities.
Additionally, the defendants instructed others to destroy evidence once they became aware that they were under investigation. Downing Labs, LLC et al. Downing and its immediate predecessor, NuVision Pharmacy, Inc. These lots of drugs were not distributed into interstate commerce. Under the proposed consent decree, Downing will be enjoined from manufacturing drugs in violation of the FDCA and will be required to cease operations until FDA determines that the company has brought its conduct into compliance with the law.
Topway Enterprises, Inc.
Perfect on Paper: The Prevalence of Fake Qualifications and their Impact
On August 29, , the district court entered a consent decree of permanent injunction against Topway Enterprises, Inc. The order permanently enjoins the defendants from processing and distributing food that is adulterated under the Food, Drug, and Cosmetic Act. USP Labs. On March 13, , the two remaining defendants in the USP Labs case pleaded guilty in Dallas to felony charges in connection with a scheme to fraudulently sell workout supplements.
Sitesh Patel, the vice president of S. Laboratories, a California dietary supplement manufacturer, pleaded guilty on February 25 to conspiracy to introduce misbranded food into interstate commerce and to the introduction of misbranded food into interstate commerce. In addition, S. Laboratories pleaded guilty on February 25 to introduction of misbranded food into interstate commerce, and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce on March 5.
The indictment alleged that the defendants misrepresented the nature and origin of the active ingredients in their products. OxyElite Pro was recalled in after being linked by the Food and Drug Administration to a deadly outbreak of serious liver injuries.
Sentencing hearings for all of the defendants will be held in Dallas before U. District Judge Sam A. Sentencing for Geissler, Doyle, Patel, and S. Laboratories is set for Aug. Sentencing for Willson and Hebert is set for Aug.