US FDA

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/11/2025
Short Title (70 char) Molecular PharmaGroup LLC. New Providence, NJ. 483 issued 08/11/2025
FEI Number 3014413265
Firm Name Molecular PharmaGroup LLC
Record Type 483
State NJ
Establishment Type Outsour

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

Fareva Amboise – 09/16/2025. Country: France. Record Type: 483

Immacule Lifesciences Private Limited – 09/18/2025. Country: India. Record Type: 483

Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted

There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators.

If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart.

Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a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.