Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller
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Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
FEI Number 3010943533
Firm Name Pine Pharmaceuticals LLC
Record Type 483
State NY
Establishment TypeTraining Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilitiesSumitomo Pharma Co., Ltd. 8/7/2025 483
Record Date: 08/7/2025
Entity Name: Sumitomo Pharma Co., Ltd.
FEI Number: 3003028650
Record Type: 483
Country: Japan
Establishment Type: Drug ManufacturerFDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026 – 01/21/2026
FDA is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026 on Wednesday, January 21, 2026.The Tranzonic Companies/Innocore Sales & Marketing Inc. – 712258 – 10/16/2025
CGMP/Finished Pharmaceuticals/AdulteratedOffice of Generic Drugs | Offices and Divisions
Generic Drugs Offices and Divisions