FDA Risk A curated home for FDA drug and device risk research Open KeyPedia Lite

Featured research

Led by KeyPedia's published studies

23 fewer FDA inspections for every extra $1B in drug imports

Imports rose. Foreign inspections fell.

Follow a foreign supplier's FDA record, free

The Foreign Inspection Gap
George Kwiecinski and Kevin Yuan, Journal of Pharmaceutical Innovation, 2026

What the research shows

See all research on KeyPedia
  1. 2012 Routines decay between inspections Anand et al.
  2. 2021 $569M+ lost per safety relabel Higgins et al.
  3. 2022 Process validation tops the list Rathore et al.
  4. 2024 Visible enforcement lifts compliance Bao et al.
  5. 2024 Warning letters per inspection up 43% Kwiecinski
  6. 2025 Stronger checks cost cents a month Wosińska
  7. 2026 Foreign inspections fall, findings stay high Kwiecinski and Yuan

Gopesh Anand, John V. Gray, and Enno Siemsen

Decay, then reset

Quality routines slip between FDA inspections. Each inspection halts the slide.

Organization Science, 2012

Matthew J. Higgins, Xin Yan, and Chirantan Chatterjee

$569M+

average loss to a drug maker from one FDA safety relabeling, up to $882M

Research Policy, 2021

Anurag S. Rathore, Yuexia Li, Hemlata Chhabra, and Akshat Lohiya

26%

of drug GMP warning letters cited process validation, the top violation

Journal of Pharmaceutical Innovation, 2022

Anurag S. Rathore, Yuexia Li, Hemlata Chhabra, and Akshat Lohiya

65%+

of pharmaceutical warning letters went to companies in Asia, mostly India and China

Journal of Pharmaceutical Innovation, 2022

Yiyi Bao, Nicholas Buhay, and Qiang Zheng

+32%

industry compliance when most firms see each enforcement action

Journal of Pharmaceutical Innovation, 2024

Marta E. Wosińska

37¢

more per month for a top generic if stronger quality checks raised its cost 25%

The Brookings Institution, 2025

Look it up, free

In KeyPedia Lite
Inspections Look up a site's FDA inspection history 483s and warning letters See what FDA found at a site Suppliers Follow a supplier's FDA record