| FluxxLab LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Wednesday, August 10, 2022
| Muscle Feast, LLC | Office of Human and Animal Foods – East 5 | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | ||||
| Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | ||||
| JB Exchange Inc./Justified Laboratories | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | ||||
| Ariella Naturals | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | ||||
| Zyno Medical LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
| InfuTronix LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
| Valley Biosystems | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program | ||||
| Vitti Labs, LLC | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Monday, August 8, 2022
Agencies issue update on ethylene oxide risk from commercial sterilizers | AHA News
Agencies issue update on ethylene oxide risk from commercial sterilizers | AHA News: The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.
| DSP Skin Care LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | ||||
| Transworld International Trading Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| FluxxLab LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
North Carolina Woman Pleads Guilty to Selling Unapproved Covid-19 Remedies
CONCORD – Diana Daffin, 69, of Charlotte, North Carolina, pleaded guilty in federal court to selling unapproved drugs with the intent to defraud or mislead the FDA, United States Attorney Jane E. Young announced today.
According to court documents and statements made in court, Diana Daffin owned and operated a holistic medicine company called Savvy Holistic Health doing business as Holistic Healthy Pet. In March 2020, the Food and Drug Administration (FDA) learned that Daffin was selling unapproved drugs on her website, with the brand name HAMPL, that Daffin claimed were COVID-19 remedies and treatments. In April and August of 2020, the FDA sent Daffin warning letters explaining that various products she was selling—including the HAMPL COVID-19 drugs—were adulterated, misbranded, and unapproved drugs and that she should take immediate action to correct the violation. Daffin responded by telling the FDA that she removed the products from her website and would stop distributing them.
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Monday, August 1, 2022
Illegal Pharmacy Operator Sentenced to Federal Prison
Distributed Hundreds of Thousands of Drugs Without Proper Prescription
A man who illegally sold thousands of doses of controlled substances and misbranded prescription drugs was sentenced today to 15 months in federal prison, fined and ordered to forfeit over $500,000 in drug proceeds.
Jon Stidham, age 57, from McClelland, Iowa, received the prison term after a January 5, 2022 guilty plea to one count of conspiracy to deliver, distribute or dispense methyltestosterone, a Schedule III controlled substance, by means of the Internet without a valid prescription and without complying with federal and Iowa licensing requirements, and one count of conspiracy to introduce misbranded drugs into interstate commerce with intent to defraud or mislead and to commit mail fraud.
In a plea agreement, Stidham admitted that he operated a business called Kennel Supply, LLC. Kennel Supply provided a variety of items used for the operation of kennels and the care of farm animals at a brick-and-mortar location. On the Internet, Kennel Supply sold controlled substances and non-controlled prescription drugs that require prescriptions to lawfully dispense to the ultimate user. From 2015 through October 12, 2018, Stidham distributed and sold over 300,000 doses of methyltestosterone, a controlled substance, without valid prescriptions, profiting $324,303. During that same time-period, Stidham illegally distributed over 50 types of misbranded prescription drugs without a valid prescription or authorization, and illegally profited $203,207.
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FDA Approves the First Generic Firocoxib Tablets for Horses
The U.S. Food and Drug Administration has approved the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses.
Firocoxib Tablets for Horses contain the same active ingredient (firocoxib) in the same concentration and dosage form as the approved brand name drug product, Equioxx Tablets, which was first approved on July 24, 2016.
Firocoxib is a nonsteroidal anti-inflammatory drug (NSAID). Like many NSAIDs, firocoxib works by affecting certain enzymes that trigger pain, fever, and inflammation.
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