Enforcement — what inspectors cite
This section reads post-inspection records as source material, not anecdote. FDA publishes the citations recorded on its system-generated Form 483s each fiscal year, and posts its warning letters in a public database, so every figure and quoted charge here can be checked against the original. The posts show what inspectors actually write down about computerised systems. FDA, Inspection Observations, published citation data by fiscal year · FDA, publication of warning letters in the Warning Letters database
Open the inspection explorer The same FDA and EU records as an interactive page: filter the inspections by year, country and classification, and read each observation in FDA's wording.
Posts in this topic
What FDA inspectors cite about computerised systems
FDA wrote 81 observations under 21 CFR 211.68(b) in FY2023 and 110 in FY2025, but per 100 drug Form 483s the rate stayed between 14.3 and 15.9. 76.8% of those observations concern who may change a master record. Part 11 itself is cited only a handful of times.