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FDA 483 Database

FDA Form 483s Issued in 2018

Every published Form FDA 483 issued in 2018, drawn from the FDA OII FOIA Electronic Reading Room. Drill into any month, or open a record to see the firm, FEI number, establishment type, and location.

227

Published 483s in 2018

12

Months with records

Browse 2018 by month

Most recent Form 483s in 2018

Showing 25 of 227 — open a month above for the full list.

  • Inspire Medical Systems Inc.FDA
    FEI
    3007666314
    Record date
    Establishment
    Manufacturer
    Location
    Minnesota, United States
  • Jiangsu Tohope Pharmaceutical Co., Ltd.FDA
    FEI
    2000019494
    Record date
    Establishment
    Dietary Supplement and Conventional Food Manufacturer
    Location
    China
  • Avella of Deer Valley dba Avella Specialty PharmacyFDA
    FEI
    3006345305
    Record date
    Establishment
    Outsourcing Facility
    Location
    Arizona, United States
  • Avella of Deer Valley dba Avella Specialty PharmacyFDA
    FEI
    3006345305
    Record date
    Establishment
    Outsourcing Facility
    Location
    Arizona, United States
  • Avella of Deer Valley dba Avella Specialty PharmacyFDA
    FEI
    3006345305
    Record date
    Establishment
    Outsourcing Facility
    Location
    Arizona, United States
  • Optum Compounding Services, LLCFDA
    FEI
    3012890460
    Record date
    Establishment
    Outsourcing Facility
    Location
    Arizona, United States
  • Fusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalFDA
    FEI
    3013341563
    Record date
    Establishment
    Producer of Sterile Drug Products
    Location
    California, United States
  • Symrise, S. de R.L. de C.V.FDA
    FEI
    3003722350
    Record date
    Establishment
    Manufacturer
    Location
    Mexico
  • Hanlim Pharm Co. Ltd.FDA
    FEI
    3004886113
    Record date
    Establishment
    Finished Pharmaceutical Manufacturer
    Location
    South Korea
  • Biotika a.s.FDA
    FEI
    3003370212
    Record date
    Establishment
    Active Pharmaceutical Ingredient Manufacturer
    Location
    Slovakia
  • Mylan Pharmaceuticals IncFDA
    FEI
    1110315
    Record date
    Establishment
    Drug Manufacturer
    Location
    West Virginia, United States
  • Magellan Diagnostics, Inc.FDA
    FEI
    1218996
    Record date
    Establishment
    Manufacturer
    Location
    Massachusetts, United States
  • Nutripack LLCFDA
    FEI
    1480280
    Record date
    Establishment
    Manufacturer
    Location
    Illinois, United States
  • Philips Medical Systems (Cleveland) IncFDA
    FEI
    1525965
    Record date
    Establishment
    Medical Device Manufacturer
    Location
    Ohio, United States
  • Biomet, Inc.FDA
    FEI
    1825034
    Record date
    Establishment
    Medical Device Manufacturer
    Location
    Indiana, United States
  • Biomet, Inc.FDA
    FEI
    1825034
    Record date
    Establishment
    Medical Device Manufacturer
    Location
    Indiana, United States
  • Park Avenue CompoundingFDA
    FEI
    1972829
    Record date
    Establishment
    Outsourcing Facility
    Location
    Missouri, United States
  • PharMEDium Services LLCFDA
    FEI
    2242985
    Record date
    Establishment
    Outsourcing Facility
    Location
    New Jersey, United States
  • Becton Dickinson & CompanyFDA
    FEI
    2243072
    Record date
    Establishment
    Initial Distributor, Manufacturer, Specification Developer
    Location
    New Jersey, United States
  • FUJIFILM Healthcare Americas CorporationFDA
    FEI
    2431293
    Record date
    Establishment
    Medical Device Manufacturer
    Location
    New Jersey, United States
  • College Pharmacy, Inc.FDA
    FEI
    1000117234
    Record date
    Establishment
    Producer of Sterile Drug Products
    Location
    Colorado, United States
  • New England Life Care, Inc.FDA
    FEI
    1000159373
    Record date
    Establishment
    Producer of Sterile Drug Products
    Location
    Maine, United States
  • Zimmer, Inc.FDA
    FEI
    1000220733
    Record date
    Establishment
    Medical Device Manufacturer
    Location
    Indiana, United States
  • Rose Acre Farms Inc. - Hyde County Egg FarmFDA
    FEI
    2000023438
    Record date
    Establishment
    Shell Egg Producer
    Location
    North Carolina, United States
  • PharMEDium Services, LLCFDA
    FEI
    3000717703
    Record date
    Establishment
    Outsourcing Facility
    Location
    Texas, United States

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