Nearly 20% Of FDA CRLs Published In 2025 Cite E&L Deficiencies. How Can You Avoid Them?

If your Extractables & Leachables (E&L) strategy isn’t built early — and built right — it can quickly turn into a regulatory roadblock. Recent FDA Complete Response Letters (CRLs) highlight this risk, with nearly 1 in 5 citing E&L-related deficiencies.

In this Q&A, Christopher Latendresse, Ph.D., Director of Analytical Services at Solvias E&L Center of Excellence, shares what a submission-ready E&L package should include and how teams can avoid preventable CRLs.