How CDMO Signal Scores Quality Compliance: A Deep Dive into FDA Data
CDMO Signal · 2026-05-23
Quality compliance is the single most important factor in selecting a CGT CDMO. It carries 35% of the total Signal Score weight. Here's exactly how we calculate it.
Data Sources
The quality pillar draws from three FDA data sources: 483 observations, warning letters, and inspection classifications (NAI/VAI/OAI).
How Inspection Outcomes Affect Scores
A CDMO with 5 consecutive NAI classifications and zero 483 observations would score near 100/100. An OAI classification with data integrity findings can drop a quality score below 50.
Why Data Integrity Matters
Data integrity findings receive the heaviest penalty. In CGT manufacturing, where products are patient-specific and often irreplaceable, data integrity failures represent systemic quality risk.