Tuesday, April 27, 2021
| 04/20/2021 | 03/24/2021 | Sky Global Food Inc | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||
| 04/20/2021 | 04/12/2021 | Hou Fu Biotech - Jiangsu Co., Ltd | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 04/27/2021 | 04/05/2021 | American Specialty Pharmacy, Inc. dba ASP Cares | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products | ||
| 04/27/2021 | 04/08/2021 | Groupe Cyrenne Inc. dba HomeoAnimal | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||
| 04/27/2021 | 04/08/2021 | Exela Pharma Sciences LLC | Office of Pharmaceutical Quality Operations, Division II | Unapproved New Drug/Compounding/Misbranding | ||
| 04/27/2021 | 04/13/2021 | Orphic Nutrition | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded | ||
| 04/27/2021 | 04/15/2021 | pharmacygeoff.md | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||
| 04/27/2021 | 04/15/2021 | Joe Wise Pharmacy, Inc., dba Wise Pharmacy | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products | ||
| 04/27/2021 | 04/23/2021 | KV Liquids LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 04/27/2021 | 04/23/2021 | Electric Freedom Inc dba Crown7 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 04/27/2021 | 04/23/2021 | DIY Vapor Supply LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 04/27/2021 | 04/23/2021 | RP Vapors, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
High Importance! Animal Drugs
As part of the FDA’s effort to protect animals, the agency issued a warning letter to Group Cyrenne Inc. dba HomeoAnimal. The company sells a “Virus Defense Kit” containing “Immunopet,” “Silverpet,” and “Cordyceps,” and misleadingly represents that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in pets. The company also markets unapproved drugs for conditions such as cancer, epilepsy, heartworm, parvovirus, and anemia. The FDA requested the company take action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Pet owners concerned about COVID-19 should consult with their veterinarians
High Importance!
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to an operator of one website, www.pharmacygeoff.md for marketing unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
Monday, April 26, 2021
Owner Of Illegal Racehorse Doping Websites Pleads Guilty In Manhattan Federal Court Scott Mangini Peddled Performance-Enhancing Drugs Including “Blast Off Red Blood Builder,” “Extreme Explosion,” “Oral Epo,” and “Green Speed”
Owner Of Illegal Racehorse Doping Websites Pleads Guilty In Manhattan Federal Court
Scott Mangini Peddled Performance-Enhancing Drugs Including “Blast Off Red Blood Builder,” “Extreme Explosion,” “Oral Epo,” and “Green Speed”
Audrey Strauss, the United States Attorney for the Southern District of New York, announced that SCOTT MANGINI pled guilty today to conspiring to unlawfully distribute adulterated and misbranded drugs with the intent to defraud and mislead, in connection with the charges filed in United States v. Robinson et al., 20 Cr. 162 (JPO). MANGINI pled guilty before U.S. District Judge J. Paul Oetken, and will be sentenced on September 10, 2021, before Judge Oetken.
U.S. Attorney Audrey Strauss said: “Scott Mangini created and flooded the supply side of a market of greed that continues to endanger racehorses through the sale of performance-enhancing drugs. Mangini designed and created dozens of products intended for use by those engaged in fraud and animal abuse. His products were manufactured with no oversight of their composition, in shoddy facilities, despite prior efforts by state and federal regulators to shut down Mangini’s operation and strip his license. Mangini’s guilty plea underscores that our Office and our partners at the FBI are committed to the prosecution and investigation of corruption, fraud, and endangerment in the horse racing industry.”
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Sunday, April 25, 2021
Department of Justice
Morris County Man Admits Role in Health Care Fraud Conspiracy, Conspiring to Obstruct Justice
CAMDEN, N.J. – A Morris County man today admitted defrauding New Jersey county health benefits programs and obstructing justice by seeking to provide false information to federal agents and the grand jury investigating the scheme, Acting U.S. Attorney Rachael A. Honig announced.
Rocco Cammalleri, 49, of Budd Lake, New Jersey, pleaded guilty by videoconference before U.S. District Judge Robert B. Kugler to an information charging him with one count of conspiracy to commit health care fraud and one count of conspiracy to obstruct justice.
According to documents filed in this case and statements made in court:
Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient is allergic to a dye or other ingredient.
In 2015, the conspirators learned that certain New Jersey local government employees, including county prison guards, had insurance coverage for these compounded medications. An entity referred to as the “Pharmacy Benefits Administrator” provided pharmacy benefit management services for the Bergen County Prescription Benefits Program (BCPBP), which covered certain local government employees, including county prison guards. The Pharmacy Benefits Administrator paid prescription drug claims and then billed the BCPBP for the amounts paid.
The conspirators learned that certain compounded medication prescriptions – including vitamins and pain, scar, antifungal, migraine, and libido creams – reimbursed thousands of dollars for a one-month supply. From September 2015 through April 2017, the conspirators – a including Cammalleri and an individual referred as Individual 2 – recruited local government employees and others to obtain medically unnecessary compounded medications. Cammalleri, who had no medical or sales background or training, recruited several individuals to receive medically unnecessary compound medications. Cammalleri and Individual 2 directed the recruits to an unnamed doctor – referred to as Individual 1 – to obtain his authorization for the compounded prescription medications. The recruits agreed to receive the very expensive compounded medications not because they needed them, but rather because they were paid to do so. Cammalleri received $175,467 in payments for the prescriptions he arranged and agreed to receive, and caused $2.98 million in fraudulent claims for compounded medications.
In 2017, Individual 2 informed Cammalleri that a federal grand jury was investigating the health care fraud conspiracy. Individual 2 and Cammalleri conspired to obstruct the federal investigation by providing and seeking to provide false information to federal agents and the grand jury.
The health care fraud conspiracy count to which Cammalleri pleaded guilty carries a maximum potential penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense, whichever is greater. The obstruction of justice conspiracy count carries a maximum penalty of five years in prison and a $250,000 fine, or twice the gross gain or loss from the offense, whichever is greater. Sentencing is scheduled for Nov. 18, 2021.
Acting U.S. Attorney Rachael A. Honig credited special agents of IRS - Criminal Investigation, under the direction of Special Agent in Charge Michael Montanez in Newark; special agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark; and special agents of the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Michael C. Mikulka, with the investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorneys Christina O. Hud and R. David Walk Jr. of the U.S. Attorney’s Office in Camden.
Tuesday, April 20, 2021
The Eleventh Circuit Issues Important Opinion on the ...
Apr 08, 2021 · On April 7, 2021, in Gil v. Winn-Dixie, Case No. 17-13467, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision on whether Title III of the Americans with Disabilities Act (“ADA”), 42 U.S.C. § 12101 et seq., is violated when a place of public accommodation (there, a grocery store) offers valuable in-store benefits to customers through a website that is ...
Blind Fla. Consumer Asks 11th Circ. To Reconsider ADA Suit ...
Looking at the public accommodation question, the majority noted that Title III of the ADA describes 12 types of locations that fall within the definition and that none were "intangible places or .