FDA 483 - Centaur Inc - February 01, 2024

Centaur Inc. in Olathe, KS, a drug manufacturer, received a Form 483 citing significant quality control deficiencies during an FDA inspection from January 29 to February 1, 2024. The firm failed to thoroughly investigate out-of-specification water system results and lacked proper sampling procedures, impacting the quality assurance of multiple drug product batches.