A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites

Abstract

The purpose of this study was to determine if any correlations could be identified from the form 483 observations issued by the US FDA during routine GMP inspections of drug substance and drug product manufacturing sites. The data analysed encompassed inspection observations from 2014 through 2018. The intent of the study is to provide unbiased insight to regulatory trends and to understand any underlying factors that may contribute to a sites non-compliance status. The data sets utilized in this study was derived from the US FDA public information database: Inspection Classification Database which was part of a 2009 open government initiative. The inspection observation data sets are ones that has been classified. The study results provide insights into domestic and foreign inspection trends. The assessment of 2014–2018 form 483 observations from FDA database revealed that the number of 483 forms issued has been on the increase however the number of observations has declined.

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Correspondence to Ajay Babu Pazhayattil.

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Pazhayattil, A.B., Ingram, M. & Sayeed, N. A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites. Ther Innov Regul Sci 54, 725–730 (2020). https://doi.org/10.1007/s43441-019-00015-3

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Keywords

  • FDA 483
  • Inspection trend
  • Establishment inspection report
  • Official Action Indicated
  • GMP