Pharmathen International S.A. 11/21/2025 483
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CGMP/Finished Pharmaceuticals/AdulteratedPharmaceutical Quality Resources
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.Denver 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 FacilityAbbreviated New Drug Application (ANDA)
Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicantsContinuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
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