Explore FDA inspection observation trends across Drugs, Biologics and Medical Devices. Click chart elements to cross-filter the dashboard, compare raw frequency with normalized rates, and drill into individual citations.
| CFR / Citation | Description | Topics | Latest freq. | Latest rate | Years |
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Frequency is the number of occurrences of an FDA standardized inspection citation in the annual dataset; it is not the number of firms or Form 483s.
Normalized rate is calculated as citation frequency / Form 483 count × 100 for the selected Product Area and Fiscal Year.
Quality Topics are GMPNews analytical classifications, not fields supplied by FDA. They are assigned deterministically from CFR reference plus the FDA short and long descriptions. Classification is multi-label, so one citation may belong to more than one topic; topic totals therefore overlap and must not be summed across topics.
The dashboard is an analytical presentation of FDA-published annual inspection observation datasets. Use the linked source files and FDA source page for primary-source review.