PDA Whiteboard Paper #1: The Prevalence of AI in FDA Correspondence

The PDA Whiteboard launched as a space for the PDA community to share early-stage work and collect preliminary ratings and peer review. A member posts a document, the community reads it, and ratings accumulate over a fixed window.

George Kwiecinski, a PDA member and GKS founder, published the first paper in the series. GKS is logging and archiving the content in KeyPedia so the record stays accessible after the rating period closes.

About the Paper

The paper reviews five FDA warning letters and establishment inspection reports that reference artificial intelligence, including the April 2026 Purolea Cosmetics Lab letter, the first CDER warning letter to name AI as a contributing factor in an adulteration finding.

The core finding is grounding, not hype. AI appears as one of eight to nine observations in each document, always paired with more severe, better-established citations like quality unit failure, inadequate microbiological testing, and inadequate CAPA.

Read the abridged version on the GKS media library, and the related KeyPedia release on long-form 483 observations inside KeyPedia.

Archived Document

Community Rating

The whiteboard closed its rating period with a perfect score.

Final total ratings: 5 reviews, all 5 stars.

Explore more research in the GKS media library.