CGMP/Finished Pharmaceuticals/Adulterated
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Torrent Pharmaceuticals Limited – 585255 – 09/04/2024
CGMP/Finished Pharmaceuticals/AdulteratedUS Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 1/14/2026
Short Title (70 char) US Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
FEI Number 3010680515
Firm Name US Specialty Formulations LLC
Record Type 483
State PA
Establishment Type OutsouLEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/09/2025
Short Title (70 char) LEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025
FEI Number 3010166880
Firm Name LEESAR, Inc.
Record Type 483
State FL
Establishment Type Outsourcing FacilityClosed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.Q&A on CGMP Requirements
Pharmaceutical Quality/Manufacturing Standards (CGMP)Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.