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Inspections and Audits

Home » Topics » Pharmaceuticals » Inspections and Audits
  • January 24, 2023

    Maker of Sterile PRE-PEN Slapped With 11-Observation 483

    Plainville, Conn.,-based AllerQuest, maker of the sterile PRE-PEN Injection — a drug that tests for penicillin allergy before administering a dose of penicillin — was hit with an 11-observation Form 483 for failure to isolate operators from aseptic filling equipment, poor airflow and other lapses.
  • January 23, 2023

    ‘Cascade of Failure’ Leads to Form 483 for Intas Pharma

    Intas Pharmaceuticals was hit with a 36-page, 11-observation Form 483 following an inspection of its facility in Ahmedabad, India, that reads like a comedy of errors.
  • January 19, 2023

    API Maker Marcus Research Lab Hit With Nine-Observation 483

    Marcus Research Laboratory of St. Louis, Mo., was slapped with a nine-observation Form 483 for deficiencies ranging from walls and floors so covered in the facility’s active pharmaceutical ingredient (API) that one investigator’s feet got stuck to the floor, to batch production records missing several key steps.
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  • January 18, 2023

    FDA Commissioners Past and Present Discuss Future of Accelerated Approvals

  • January 9, 2023

    FDA Warns Online Pharmacy for Selling Drugs That Require a REMS

  • January 6, 2023

    FDA Warns Internet Pharmacy Against Selling Drugs That Require a REMS

  • January 4, 2023

    Smithfield Bioscience Draws Form 483 Over Repeat Batch Discrepancies

  • January 4, 2023

    Form 483s in Fiscal 2022 Show FDA Targeting Sterility, Contamination Issues

  • December 30, 2022

    FDA Issues Warning Letter for Unapproved, Contaminated Nasal Spray

  • December 29, 2022

    FDA Raps OTC Drugmaker for Lax Testing and Maintenance

  • December 29, 2022

    FDA Issues Warning Letter for Unapproved, Contaminated Nasal Spray

  • December 28, 2022

    Granules Pharmaceuticals Gets Form 483 for Inadequate Quality and Production Procedures

  • December 22, 2022

    Brazilian API Maker Draws Warning Letter for Data Integrity and Batch Control Issues

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