Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Fagron Compounding Services. Wichita, KS. 483 issued 08/08/2025
FEI Number 3012104093
Firm Name Fagron Compounding Services
Record Type 483
State KS
Similar Posts
BsUFA IV: Fiscal Years 2028-2032
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.Sleep, Skin, Bodybuilding and Other Product Notifications
Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
FEI Number 3014982757
Firm Name FarmaKeio Outsourcing LLC
Record Type 483
State TX
Establishment Type OutsourcingHeparin Importation
Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.Accelerated Approval Program
To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint