CGMP/Finished Pharmaceuticals/Adulterated
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IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/25/2025
Short Title (70 char) IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
FEI Number 3014483112
Firm Name IntegraDose Compounding Services LLC
Record Type 483
State MN
EstabliMark J. Savant, M.D – 712306 – 06/26/2025
Clinical InvestigatorRecall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip endBiomarker Qualification Program
The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods
Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.