CGMP/Finished Pharmaceuticals/Adulterated
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Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program (CDRP)Medi-Fare Drug Pharmaceutical Compounding LLC. Blacksburg, SC. 483 issued 06/06/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/06/2025
Short Title (70 char) Medi-Fare Drug Pharmaceutical Compounding LLC. Blacksburg, SC. 483 issued 06/06/2025
FEI Number 3009925820
Firm Name Medi-Fare Drug Pharmaceutical Compounding LLC
Record Type 483Natural MiracleZEN Platinum 70000 may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN Platinum 70000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Nefeteri Wellness – 709332 – 05/30/2025
Unapproved New DrugsLil’ Turtles Issues a Voluntary Recall Due to Undeclared Milk Allergen
Baltic, OH (Dec. 4, 2025) – Lil’ Turtles is recalling all lots of its Grandma Belle’s Tomato Basil Soup for misbranding due to the milk allergen not being declared on the label. The Grandma Belle’s Tomato Basil Soup was packaged in 17 oz glass jars.Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.