News about GMP/cGMP

22.10.2021

FDA: Inspectional Observations 2021 published

FDA: Inspectional Observations 2021 published

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.


In form of Excel spreadsheets, the area of regulation and the number of times it was cited are listed along with a description of the finding. The following categories were classified and evaluated:

 

For the area of drugs, these Top 3 findings are listed:

  • Procedures not in writing, fully followed (80)
  • Investigations of discrepancies, failures (49)
  • Scientifically sound laboratory controls(44)

For the area of medical devices, the Top 3 findings are:

  • Lack of inadequate procedures (77)
  • Lack of inadequate complaint procedures (49)
  • Purchasing controls, lack of inadequate procedures (31)

For more details, please find a downloadable data set with the inspectional observations in 2021 here.


Source:

FDA: ORA, Inspectional Observations


 

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