# FDA Risk

> FDA Risk collects clear, sourced facts from published research on FDA drug and device oversight: inspections, warning letters, and what drives quality risk at suppliers. Each fact links to the paper it came from. FDA Risk is powered by KeyPedia, where the underlying FDA records can be searched free in KeyPedia Lite.

Every fact on FDA Risk comes from a published paper and links to it. Numbers are taken from published abstracts or full texts, never preprints. The whole site is one page.

## Site

- [FDA Risk as Markdown](https://www.fdarisk.com/index.md): the full page, with each fact's data, source, and evidence basis
- [Full text for LLMs](https://www.fdarisk.com/llms-full.txt): the same content in one file

## Facts

- [23 fewer FDA inspections for every extra $1B in drug imports](https://doi.org/10.1007/s12247-026-10406-3): Kwiecinski and Yuan, Journal of Pharmaceutical Innovation, 2026.
- [Decay, then reset: Quality routines slip between FDA inspections. Each inspection halts the slide.](https://doi.org/10.1287/orsc.1110.0709): Anand et al., Organization Science, 2012.
- [$569M+ average loss to a drug maker from one FDA safety relabeling, up to $882M](https://doi.org/10.1016/j.respol.2020.104126): Higgins et al., Research Policy, 2021.
- [26% of drug GMP warning letters cited process validation, the top violation](https://doi.org/10.1007/s12247-022-09678-2): Rathore et al., Journal of Pharmaceutical Innovation, 2022.
- [65%+ of pharmaceutical warning letters went to companies in Asia, mostly India and China](https://doi.org/10.1007/s12247-022-09678-2): Rathore et al., Journal of Pharmaceutical Innovation, 2022.
- [+32% industry compliance when most firms see each enforcement action](https://doi.org/10.1007/s12247-024-09825-x): Bao et al., Journal of Pharmaceutical Innovation, 2024.
- [43% more warning letters per 100 FDA inspections, 2019 to 2023](https://doi.org/10.1007/s12247-024-09879-x): Kwiecinski, Journal of Pharmaceutical Innovation, 2024.
- [2.3× the rate of drug warning letters per 100 inspections, 2023 vs 2019](https://doi.org/10.1007/s12247-024-09879-x): Kwiecinski, Journal of Pharmaceutical Innovation, 2024.
- [37¢ more per month for a top generic if stronger quality checks raised its cost 25%](https://www.brookings.edu/articles/rethinking-manufacturing-quality-oversight-for-prescription-drugs/): Wosińska, The Brookings Institution, 2025.
- [69.0% of FDA inspections in China ended with findings. The U.S. rate is 49.3%.](https://doi.org/10.1007/s12247-026-10406-3): Kwiecinski and Yuan, Journal of Pharmaceutical Innovation, 2026.

## Look up FDA records

- [FDA inspections in KeyPedia Lite](https://www.keypedia.com/records/fda_inspections?utm_source=fdarisk&utm_medium=llms&utm_campaign=llms&utm_content=inspections): inspection history by site
- [FDA Form 483s in KeyPedia Lite](https://www.keypedia.com/records/483?utm_source=fdarisk&utm_medium=llms&utm_campaign=llms&utm_content=483s): investigator observations
- [FDA warning letters in KeyPedia Lite](https://www.keypedia.com/records/warning_letter?utm_source=fdarisk&utm_medium=llms&utm_campaign=llms&utm_content=warning-letters): warning letters by company

## Optional

- [KeyPedia research library](https://www.keypedia.com/platform/documentation): all research KeyPedia tracks
- [KeyPedia llms.txt](https://www.keypedia.com/llms.txt): KeyPedia's own index for AI tools