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FDA Warning Letter & Inspection Observation Trends …

    https://www.thefdagroup.com/blog/2019-fda-warning-letter-inspection-observation-trends
    “As in past years, the majority of Warning Letters in FY2020 were issued to sites with non-application products (69%), and especially those that manufacture finished dosage form (FDF), non-sterile, non-application products (41% of all Warning Letters).” “Import Alerts doubled to 128 in FY2020. Latin America had t… See more

Current Compliance Trends - Food and Drug …

    https://www.fda.gov/media/142010/download
    FDA Device Inspections www.fda.gov 11 FY2019 QS Medical Device Inspections Total Domestic Inspections Total Foreign Inspection 12 Top 5 Device QSR FDA 483 …

Device warning letters plunged nearly 90% over 5 years.

    https://www.medtechdive.com/news/device-warning-letters-plunged-nearly-90-over-5-years-an-fda-official-pre/570175/
    Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound. FDA warning letters to medical device manufacturers slid by …

Medical Device Warning Letter Statistics for the first Half …

    https://www.gmp-compliance.org/gmp-news/medical-device-warning-letter-statistics-for-the-first-half-of-the-fiscal-year-2020
    Warning Letters on misbranded and adulterated products with regard to Covid-19 were generally not included. The semi-annual statistics Fiscal year 2020. …



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