FDA Warning Letters Analytics

Interactive trends, GMP topics, regulatory topics and direct links to FDA Warning Letters
Source: U.S. FDA Warning Letters  |  Help / How to use  |  GMPNews.org
About this dashboard: FDA Warning Letters Analytics provides an interactive view of publicly available U.S. FDA Warning Letters. It supports analysis of issue-date trends, FDA subjects, issuing offices, GMP topics, regulatory/CFR topics and full Warning Letter text. AI-assisted classifications and summaries are clearly distinguished from FDA source information, while each record links back to the original FDA Warning Letter.
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GMP Topic Heatmap — Last 5 Years

Compare the relative importance of the most frequent GMP topics across the latest five years. Darker cells indicate a higher percentage share of Warning Letters in a given year. Click a cell to filter the dashboard by year and GMP topic.
Cell number = Warning Letters containing the GMP topic. Percentage = share of Warning Letters in that year. Heatmap columns always represent the latest five years available in the FDA Warning Letter dataset.

Topic Trend Analysis

Analyse how frequently a selected analytical Topic appears over time. By default, the panel covers Warning Letters containing at least one standard GMP or Regulatory Topic: GMP01–GMP20 or REG01–REG23. Catch-all / non-standard codes GMP00, GMP99, REG90 and REG99 are excluded. Bars show the number of Warning Letters containing the selected topic. The line shows its percentage share in the comparable population. Click a blue bar to filter the whole dashboard by the selected year or month.
Selected topic: All standard Topics (GMP + Regulatory) Topic selector affects this analysis panel only; analytics use Warning Letter issue date
Current period — Warning Letters
Comparison period — Warning Letters
Count change — Compared with reference period
Current share — —
Select a GMP Topic or Regulatory Topic from the filters above to display trend and period comparison.
Issue date Posted date Company GMP Topics Regulatory Topics Issuing office Subject FDA link
Warning Letters in the table are ordered by FDA posting date. The table displays both Warning Letter issue date and FDA posting date. Trend analyses and Year/Month filters use Warning Letter issue date. Click chart elements, heatmap cells, KPI cards, GMP/Regulatory codes or filters to cross-filter the dashboard. Click elsewhere in a Warning Letter row to open analytical details. Search covers dashboard fields plus full Warning Letter text. The full-text search index is loaded only when search is used.
Disclaimer: Analytical classifications, topic assignments, summaries and derived insights are generated using automated algorithms supported by artificial intelligence. They are provided for informational and analytical purposes only and do not represent official FDA classifications or interpretations. Users should verify relevant information against the original FDA Warning Letter and other official FDA sources.
Dashboard views: —

AI Summary AI-assisted

GMP Topics AI-assisted

Regulatory Topics AI-assisted

Classification Evidence AI-assisted

CFR Citations

Full Warning Letter Text

FDA source

Open original FDA Warning Letter ↗