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FDA 483 Database

FDA Form 483s Issued in November 2025

Every published Form FDA 483 issued in November 2025, drawn from the FDA OII FOIA Electronic Reading Room. Each row links to the FDA source record.

16

Published 483s in November 2025

16

Distinct firms

Form 483s issued in November 2025

  • BAXALTA US INC.FDA
    FEI
    3012385969
    Record date
    Establishment
    Plasma Derivative Manufacturer
    Location
    Illinois, United States
  • Wacker Biotech B.V.FDA
    FEI
    3008539577
    Record date
    Establishment
    Drug Substance Manufacturer
    Location
    Netherlands
  • Americord Registry LLCFDA
    FEI
    3006988080
    Record date
    Establishment
    Human Tissue
    Location
    New Jersey, United States
  • Baxalta US Inc.FDA
    FEI
    1000519965
    Record date
    Establishment
    Plasma Derivative Manufacturer
    Location
    Illinois, United States
  • Gland Chemicals Private LimitedFDA
    FEI
    3008386908
    Record date
    Establishment
    03/13/2026
    Location
    India
  • Lupin LimitedFDA
    FEI
    3004819820
    Record date
    Establishment
    Drug Manufacturer
    Location
    India
  • Asahi Kasei Finechem Co., Ltd.FDA
    FEI
    3002806404
    Record date
    Establishment
    API (animal origin) Manufacturer
    Location
    Japan
  • Pine Pharmaceuticals, LLCFDA
    FEI
    3010943533
    Record date
    Establishment
    Outsourcing Facility
    Location
    New York, United States
  • Sato Pharmaceutical Co., Ltd.FDA
    FEI
    3004055563
    Record date
    Establishment
    01/21/2026
    Location
    Japan
  • Fresenius Kabi Compounding, LLCFDA
    FEI
    3013438665
    Record date
    Establishment
    Outsourcing Facility
    Location
    Massachusetts, United States
  • OSRX Inc.FDA
    FEI
    3014549846
    Record date
    Establishment
    Outsourcing Facility
    Location
    Montana, United States
  • Shilpa Medicare LimitedFDA
    FEI
    3009876430
    Record date
    Establishment
    Drug Manufacturer
    Location
    India
  • Pharmathen International S.A.FDA
    FEI
    3009961173
    Record date
    Establishment
    Finished Pharmaceutical Manufacturer
    Location
    Greece
  • Delta Pharma, Inc.FDA
    FEI
    3004034796
    Record date
    Establishment
    Outsourcing Facility
    Location
    Mississippi, United States
  • Empower Clinic Services, LLC dba Empower PharmacyFDA
    FEI
    3021758709
    Record date
    Establishment
    Producer of Sterile and Non Sterile Drug Products
    Location
    Texas, United States
  • TAILSTORM HEALTH INCFDA
    FEI
    3022483154
    Record date
    Establishment
    Outsourcing Facility
    Location
    Arizona, United States

Other months in 2025

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