Devalingam Mahalingam, M.D., Ph.D. – 721145 – 12/11/2025
Clinical Investigator
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Unipack LLC – 716621 – 12/19/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Agebox Inc. – 718252 – 12/19/2025
Unapproved New Drug/Misbranded -
Private Label Skin Care, Inc. – 715880 – 12/18/2025
CGMP/OTC/Adulterated/Misbranded -
Field Safety Notices: 22-26 December 2025
List of Field Safety Notices for 22-26 December 2025
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Walgreen Company – 662158 – 09/12/2023
Failure to Register and List -
Walgreen Company – 662158 – 12/19/2025
Failure to Register and List -
Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems -
Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
A defect was discovered in the Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 that may cause the app to shut down unexpectedly. -
Sun Pharmaceuticals Medicare Ltd. 9/19/2025
Record Date: 9/19/2025
Entity Name: Sun Pharmaceuticals Medicare Ltd.
FEI Number: 3002957541
Record Type: 483
Country: India
Establishment Type: Sterile Drug Manufacturer -
Pharmathen International S.A.11/21/2025 483
Pharmathen International S.A. 11/21/2025 483 -
CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.