Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, August 5, 2023
Bulk Drug Substances Currently Under Review
FDA‑2018‑N‑4626‑0106 https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-currently-under-review https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-currently-under-review |
Mark Cuban Cost Plus Drugs inks partnership with pharmacy navigation startup Scripta
By Anastassia Gliadkovskaya
Wednesday, July 26, 2023
Fuller Industries Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | ||||
Edge Biologicals Inc. | Division of Medical Device and Radiological Health Operations Central | CGMP/QSR/Medical Devices/Adulterated | ||||
Eden’s Answers, Inc. | Division of Human and Animal Food Operations East V | CGMP/Dietary Supplement/Adulterated | ||||
Wisetrade Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
Ocalsa Transport & Logistics, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
Bella Mia Foods, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
Centaur Pharmaceuticals Private Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
Outset Medical, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated | ||||
The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Vapor Sense League City | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Northland Vapor Company, LLC | Division of Human and Animal Food Operations West I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
Gadget Island, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
Five Leaf Pet Botanicals, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
Koi CBD, LLC | Division of Human and Animal Food Operations West V | Adulterated Human Foods/Misbranded | ||||
Wise Women’s Choice | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
Baits and Sea Foods, S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
Cheshni Foods LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
Stratus Biosystems, LLC dba CellGenuity Regenerative Science | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
Vapor Sense LLC d/b/a Vapor Sense E-Cigs & Supplies | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Mountain Vaporz LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Department of Justice News: Thoroughbred Racehorse Trainer Jason Servis Sentenced To Four Years In Prison
Department of Justice News: Thoroughbred Racehorse Trainer Jason Servis Sentenced To Four Years In Prison
Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant JASON SERVIS was sentenced to four years in prison today for his role in a years-long scheme in which horses trained by SERVIS were doped with approved and unapproved drugs designed to improve the performance of SERVIS’s racehorses, in connection with the charges filed in United States v. Navarro et al., 20 Cr. 160 (MKV). SERVIS was one of over 30 defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs (“PEDs”).