RC Outsourcing, LLC. Lowellville, OH. 483 issued 08/28/2025

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Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration

CGMP/Finished Pharmaceuticals/Adulterated

Clinical Investigator/Sponsor

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco

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 Fa