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Inspections and Audits

Home » Topics » Pharmaceuticals » Inspections and Audits
  • May 11, 2022

    SAFC Carlsbad Dinged for Unsafe Biohazard Practices, Alarm Problems

    The FDA hit Carlsbad, Calif.-based SAFC Carlsbad — a MilliporeSigma property — with a seven-observation Form 483 following a December 2021 inspection, citing inadequate handling of biohazardous materials and other quality lapses.
  • May 5, 2022

    Contract Testing Lab Gets Warning Letter for Falsified Data, Other cGMP Deviations

    The FDA issued a warning letter to a contract testing laboratory at Miami University in Oxford, Ohio, for significant deviations from current good manufacturing practice (cGMP), including falsified data.
  • April 20, 2022

    Indian Generics Maker Hit With 483 Over Operations at API Facility

    Mumbai, India-based generic drugmaker Lupin has received another Form 483 inspection report from the FDA.
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  • March 25, 2022

    Minnesota Facility Cited for Quality Lapses, Some Repeated

  • March 23, 2022

    Belcher Pharmaceuticals Receives Form 483 for Lab and Production Quality Issues

  • March 22, 2022

    Baxter Gets Form 483 for Observations of Recurring Vermin, Lack of Protocols and Access

  • March 18, 2022

    New Jersey Compounding Pharmacy Cited for Lax Quality, Sterility

  • March 16, 2022

    FDA Cites New Jersey Plant for Quality Deficiencies

  • March 15, 2022

    Puerto Rico OTC Facility Cited for Lab Operations, Cleanliness Observations

  • March 14, 2022

    Gingi-Pak Draws Form 483 for Failing to Conduct Microbiological Testing

  • March 11, 2022

    Janssen’s Puerto Rico Plant Receives Form 483 for Multiple Quality Unit Lapses

  • March 10, 2022

    Catalent Facility Cited for Equipment, Validation Lapses

  • February 28, 2022

    Mumbai-based Macleods Pharmaceuticals Receives 483 Noting Unclean Equipment

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Events

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  • 09Jun

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  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

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