CGMP/Finished Pharmaceuticals/Adulterated
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Nutrishus Brands, Inc. – 612938 – 07/28/2021
Unapproved New Drugs/MisbrandedMedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/10/2025
Short Title (70 char) MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
FEI Number 3013316698
Firm Name MedisourceRx
Record Type 483
State CAHealBerry – 09/09/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetFDA’s ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)
FDA accepts first letter of intent (LOI) into the ISTAND Pilot Program for an organ-on-a-chip technology, a type of micro-physiological system (MPS), to study drug-induced liver injury (DILI) for certain drug candidates.Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
FEI Number 3022897129
Firm Name Hikma Injectables USA Inc.
Record Type 483
State NJ
Establishment Type Outsourcing FaNew 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 expirati