07/18/2023	06/28/2023	Fuller Industries Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
07/18/2023	06/27/2023	Edge Biologicals Inc.	Division of Medical Device and Radiological Health Operations Central	CGMP/QSR/Medical Devices/Adulterated
07/18/2023	06/28/2023	Eden’s Answers, Inc.	Division of Human and Animal Food Operations East V	CGMP/Dietary Supplement/Adulterated
07/18/2023	06/30/2023	Wisetrade Corporation	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
07/18/2023	06/22/2023	Ocalsa Transport & Logistics, LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
07/18/2023	07/06/2023	Bella Mia Foods, Inc.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
07/18/2023	06/05/2023	Centaur Pharmaceuticals Private Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
07/18/2023	07/05/2023	Outset Medical, Inc.	Center for Devices and Radiological Health	Premarket Approval/Adulterated
07/13/2023	07/13/2023	The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/13/2023	07/13/2023	Vapor Sense League City	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

 

07/25/2023	07/07/2023	Northland Vapor Company, LLC	Division of Human and Animal Food Operations West I	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
07/25/2023	07/21/2023	Gadget Island, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
07/25/2023	06/22/2023	Five Leaf Pet Botanicals, Inc.	Center for Veterinary Medicine	Unapproved New Animal Drug Products
07/25/2023	07/18/2023	Koi CBD, LLC	Division of Human and Animal Food Operations West V	Adulterated Human Foods/Misbranded
07/25/2023	07/20/2023	Wise Women’s Choice	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
07/25/2023	06/30/2023	Baits and Sea Foods, S.A.	Center for Food Safety and Applied Nutrition (CFSAN)	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
07/25/2023	06/14/2023	Cheshni Foods LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
07/25/2023	06/05/2023	Stratus Biosystems, LLC dba CellGenuity Regenerative Science	Division of Biological Products Operations II	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
07/21/2023	07/20/2023	Vapor Sense LLC d/b/a Vapor Sense E-Cigs & Supplies	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2023	07/20/2023	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

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”).

 

Amendments to the Food and Drug Regulations ...

Canada.ca

https://www.canada.ca › forward-regulatory-plan › plan

4 hours ago — A new regulatory framework to address commercial compounding is being developed with the aim to fill a current gap in regulatory oversight.

 

The Wholesaling Prohibition (Potentially) Demystified? ...

FDA Law Blog

https://www.thefdalawblog.com › 2023/07

5 days ago — Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions ..

 

US FDA Provides Recommendations on the Statutory ...

RegASK

https://regask.com › us-fda-provides-recommendation...

1 day ago — US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling for Certain Compounded Drugs ... According to FDA, this draft guidance describes the 

 

July 2023 – Resolutions | Ohio Board of Pharmacy

Ohio.gov

https://www.pharmacy.ohio.gov › boardmeeting

4 days ago — As used in this resolution “originating facility” means the facility where compounded medication administration occurs and “compounding facility” means the .

 

Pharmacy Inspection Deficiency Monetary Penalty Guide

Virginia (.gov)

https://www.dhp.virginia.gov › guidelines

5 days ago — 20b. Pharmacist not documenting verification of accuracy of sterile compounding process and integrity of compounded products. 54.1-3410.2,. 18VAC110-20-355.

 

Compounding warning letters to 503A facilities between ...

ScienceDirect

https://www.sciencedirect.com › science › article › pii

by Q Zhang · 2023 — The content of warning letter violations was analyzed in terms of both the compounding environment and 503A facilities that did not received valid prescriptions .

 

Novo Nordisk sues 4 more companies for making illegal ...

Fierce Pharma

https://www.fiercepharma.com › pharma › novo-nordi...

3 hours ago — In federal courts in Florida and Tennessee, Novo Nordisk has accused four pharmacies of making unauthorized compounded versions of Ozempic and Wegovy.