CGMP/Finished Pharmaceuticals/Adulterated
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Data Standards Program Strategic Plan and Board
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.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
EstabliAdvanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/22/2024
Short Title (70 char) Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
FEI Number 3010039017
Firm Name Advanced Nutriceuticals LLC
Record Type 483
State IN
Establishment Type SteriVITAFER-L Gold 20ml may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 20ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com.Animal Model Qualification Program | AMQP
Information for requestors interested in submitting animal models for qualification to FDA’s Drug Development Tool (DDT) Programs.Junebar Issues Allergy Alert on Undeclared Milk and Soy in Chocolate Cherry and Peanut Butter Chocolate Chip Flavor Bars
Juniper Granola, LLC. of Rochester, NY is recalling CHOCOLATE CHERRY and PEANUT BUTTER CHOCOLATE CHIP Junebars with printed batch label L1300 or L1301 because it may contain undeclared milk and soy. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threa