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
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Chetak LLC Group Recalls Product Because of Possible Health Risk
Are recalling Frozen ‘Deep Sprouted Mat(Moth) 16 oz. and Deep Sprouted Moong 16oz. because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people and others with weakened immune system.www.plakini-pharma.com – 705185 – 07/16/2025
Unapproved New Drugs/MisbrandedDenver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing Facility2023 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
This page contains the meeting materials for the Cardiovascular & Renal Drugs Advisory Committee meetings for 2023.New Hoque & Sons Inc Issues Alert on Uneviscerated “Dry Ghoinnya Fish”
New Hoque & Sons Inc. of Maspeth, NY, is recalling its packages of “Dry Ghoinnya Fish” because the product was found to be uneviscerated.The recalled “Dry Ghoinnya Fish” were distributed nationwide in retail stores. The product comes in a 10-12 pound, clear plastic package marked with an expiratiApollo Care LLC. Columbia, MO. 483 issued 03/27/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/27/2025
Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
FEI Number 3013927023
Firm Name Apollo Care LLC
Record Type 483
State MO
Establishment Type Outsourcing Facility