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After obtaining payment, company employees made little effort to obtain modifications. Ronald Rodis was paid for the use of his law license in an effort to lend legitimacy to the operation. KFJ Marketing et al. On March 10, , the government filed a complaint against KFJ Marketing, Sunlight Solar Leads LLC, Go Green Education, and the owner of those companies, Francisco Salvat, to halt a telemarketing campaign which failed to transmit accurate caller identification information, and resulted in 1. The complaint alleges that when consumers asked the defendants not to call them again, their requests were often ignored.
Indivior Inc. On April 9, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. ACell, Inc. On June 11, , ACell, Inc. ACell manufactures and distributes MicroMatrix, a powder wound dressing produced from porcine bladder tissue. In pleading guilty, ACell admitted that in it determined that more than 30, MicroMatrix devices were contaminated with high levels of endotoxin, which posed a risk to patient health ACell also admitted that it initiated a removal of MicroMatrix devices from sales representative inventories, hospitals, and other healthcare centers, but did not notify FDA of the removal or of the endotoxin contamination.
ACell further admitted that it did not notify doctors who already had purchased or used contaminated MicroMatrix about the removal. Cesar B.
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Pena Rodriguez, M. Mendez, M. On June 4, , the district court entered two stipulated preliminary injunction orders against doctors Cesar B. Pena Rodriguez and Leovares A.
Mendez to stop them from unlawfully prescribing powerful opioids linked to abuse and diversion. According to the complaint, the defendants issued thousands of prescriptions without apparent regard for patient harm, including prescriptions for a dangerous combination of an opioid, short-acting benzodiazepine, and a muscle relaxer. The complaint further alleges that the defendants issued numerous purported prescriptions without a legitimate medical purpose and outside the usual course of professional practice to undercover agents of the United States Drug Enforcement Administration.
The court previously entered a temporary restraining order against the defendants on May 8, On May 22, , the district court entered a consent decree of permanent injunction requiring a multi-state outsourcing compounding pharmacy and two of its executives to comply with provisions of the Food, Drug, and Cosmetic Act FDCA while manufacturing, holding, and distributing drugs. The complaint also alleged that PharMedium distributed unapproved new drugs and misbranded drugs by failing to comply with requirements for drugs compounded in a registered outsourcing facility.
As part of the settlement, PharMedium may not manufacture, hold, or distribute its drugs from its Tennessee facility unless PharMedium complies with specific remedial measures set forth in the consent decree.
PharMedium also must take remedial measures to ensure compliance with the FDCA at its other facilities and at its headquarters in Illinois. Yabe, Hisao.
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The convictions stem from a series of incidents in which multiple patients at hospitals in Europe and the United States experienced serious infections after being treated with a duodenoscope manufactured by Olympus. District Judge Stanley R. On May 8, , the court sentenced Matthew Dailey to 24 months in prison for the illegal importation and sale of kratom, which he sold to consumers as a purported treatment for various serious diseases and medical conditions, including opiate withdrawal symptoms.
Dailey was the owner and operator of Nomad Botanicals, an online business that sold kratom to consumers throughout the United States. Dailey pleaded guilty on January 8, to one count of introducing misbranded drugs into interstate commerce and one count of importing merchandise contrary to law. Levy also sentenced Dailey to three years of supervised release. On April 29, , Caprice R. Bearden was sentenced in Indianapolis for her role in a conspiracy to defraud the U.
Food and Drug Administration concerning the distribution of under- and over-potent compounded drugs. Bearden, the former compliance director of Pharmakon Pharmaceuticals, Inc. Pharmakon , of Noblesville, Indiana, pleaded guilty in November to conspiracy and nine counts of adulterating drugs. In pleading guilty, Bearden admitted that she and her co-defendant, Paul J.
Elmer was convicted of conspiracy and nine counts of adulteration on April 10, , following a jury trial trial. Lytle argued on appeal, inter alia, that his plea was obtained by coercion, that he was not competent to plead guilty, and that his counsel was ineffective. On April 9, , a grand jury returned and indictment against Indivior Inc. The indictment charges Indivior with mail, wire, and health care fraud conspiracy and substantive counts. The indictment alleges that Indivior obtained billions of dollars in revenue from Suboxone Film prescriptions by deceiving health care providers and health care benefit programs into believing that Suboxone Film was safer, less divertible, and less abusable than other opioid-addiction treatment drugs.
Arraignment is scheduled for May 6 in Abington, Virginia. Innovative BioDefense, Inc. Docket Number: CV C. United States. Oakley Pharmacy, Inc. Docket Number: CV-9 M. On February 7, , U. District Judge Aleta Trauger issued a temporary restraining order against two Celina, Tennessee pharmacies, their majority owner, and three pharmacists, stopping them from continuing to dispense controlled substances.
Specifically, the complaint alleges that the defendants routinely dispensed controlled substances while ignoring numerous warning signs of diversion and abuse, such as unusually high dosages of oxycodone and other opioids, prescriptions for opioids and other controlled substances in dangerous combinations, and patients travelling extremely long distances to obtain and fill prescriptions.
The complaint alleges that the two rural pharmacies are among the highest purchasers of opioids per capita in the entire country. In addition to seeking injunctive and civil monetary penalty relief for violations of the CSA, the complaint also contains allegations under the False Claims Act for falsely billing Medicare for illegally dispensed controlled substance prescriptions.
Docket Number: CV W. In a complaint filed February 1, , the United States alleged that the defendants violated the Food, Drug, and Cosmetic Act by causing drugs to become adulterated. Specifically, the complaint alleged that multiple FDA inspections revealed that the defendants compounded sterile drugs under insanitary conditions.
As part of the consent decree, the defendants represented that they no longer engage in sterile compounding. According to the plea agreement, Onyx was approved by the U. Food and Drug Administration FDA as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain..
The FDA has approved Onyx only for use inside the brain. Olympus Medical Systems Corp. 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. Yabe is scheduled to be sentenced on March Keystone Laboratories, Inc. The order also provides safeguards in the event that the defendants contract with third parties to manufacture similar products. In a July complaint, the government alleged that the defendants promoted and sold misbranded sexual enhancement products that contained the undisclosed ingredient sildenafil, which is the active pharmaceutical ingredient in Viagra.
The defendants did not respond to the complaint, and the court ordered them to cease distribution of all drugs until the companies implement specified remedial measures to ensure compliance with the FDCA. Gregory J. Gerber, M. Michael P. Tricaso, D. On August 22, , civil enforcement actions under the Controlled Substances Act were unsealed against two physicians alleging the illegal distribution and dispensing of opioids and other controlled substances.
The complaints were filed by the U. The complaint against Michael Tricaso, D. For more information, see the press release issued August 22, On August 2, , 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.
Contrary to these agreements, Turner sold the drugs to drug wholesalers at higher prices. Turner also admitted that after her first fraudulent pharmacy was closed for drug diversion, she started an identical drug diversion scheme in a neighboring state. Delta Pharma, Inc.
On June 8, , the district court entered a consent decree of permanent injunction against Delta Pharma, Inc. Tommy T.
Simpson, and its Vice President and Pharmacist in Charge, Charles Michael Harrison, permanently enjoining the defendants from manufacturing and distributing compounded drugs that are adulterated under the Food, Drug, and Cosmetic Act. According to the complaints, both sets of defendants manufacture their products without FDA approval and without proof of safety and efficacy. According to the complaints, the defendants and their affiliates have used their products on thousands of patients without obtaining necessary FDA approvals.
On March 27, , the district court permanently enjoined dietary supplement distributor MyNicNaxs LLC, and two principals of the company, Chevonne Torres and Michael Banner, from selling and distributing unapproved and misbranded new drugs. In a complaint filed on March 14, the United States alleged that the Florida company sold sexual enhancement and weight loss products in violation of the Federal Food, Drug, and Cosmetic Act.
The complaint alleged that the defendants marketed such products as drugs to treat serious conditions without FDA approval and without proof of safety and efficacy. The consent decree entered by the court requires the defendants to implement specific remedial measures to comply with the law and obtain written approval from the FDA before distributing such drugs in the future. Cantrell Drug Co. On Feb. McCarley, Jr. The complaint alleges that Cantrell, a compounding pharmacy, distributed adulterated drugs in interstate commerce and caused drugs to become adulterated while held for sale after shipment of a component in interstate commerce.
Cantrell initiated voluntary recalls of drug products in and due to a lack of sterility assurance. According to the complaint, FDA inspections of the Cantrell facility documented evidence of insanitary conditions and significant deviations from current good manufacturing practice requirements, including records showing the company detected potentially dangerous bacteria in the air and on surfaces used for sterile processing.
Aegerion Pharmaceuticals, Inc. Docket Number: CR D.