In Vivo Bioavailability-Bioequivalence Studies – Clinical
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Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used.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 FaClinical Outcome Assessments (COA) Qualification Program Submissions
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