FDA 483 - Summit Biosciences Inc. - February 21, 2025

An FDA inspection of Summit Biosciences Inc., a drug manufacturer in Lexington, KY, revealed two significant observations. The firm failed to implement adequate systems for Drug Supply Chain Security Act (DSCSA) verification, specifically regarding procedures for identifying and investigating suspect drug products. Additionally, the inspection found a lack of established written procedures for in-process controls, including validated 100% visual inspection and Accepted Quality Limit (AQL) inspection for particulate matter in their nasal drug products.