What is the difference between the FDA Inspection Observation and Inspection Citation reports? The inspection citation report appears to have slightly less data but provides more details for what is included.

1 Answer 1



You may find the following page on the FDA.gov site helpful:


  • Thank you for the quick response. I was looking at that page and am still unsure what the difference is between two data sets that are provided by the FDA. The inspection citation report can be found here fda.gov/ICECI/Inspections/ucm346077.htm and list company specific citations. The inspection observation reports can be found here sorted by year fda.gov/ICECI/Inspections/ucm250720.htm and list the total number each CFR was cited. Unfortunately the number of citations/CFR between the databases don't match, so I am curious as to what data was included in each report.
    – FDAcurious
    Oct 23, 2017 at 19:42
  • Please do not write link-only answers (Your answer is in another castle). Quote the essential parts in the question
    – user4293
    Apr 19, 2018 at 10:09

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