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