Lessons Learned from FDA 483s and Warning Letters

When the FDA issues a Form 483, it can foreshadow a Warning Letter, a recall, or halted production. In this on-demand session, AES Director of Process Architecture Matt Dean (RA, NCARB, LEED GA) breaks down three real cleanroom compliance failures, the most common observations FDA inspectors cite, and the design choices that either invite or prevent contamination risk. Practical takeaways for quality, facility, and operations leaders scaling from clinical to commercial.

Drawing on 15 years of biopharma and life sciences design experience, Matt offers candid, design-rooted insight you can apply to your next project, expansion, or compliance review.