FDA 483 - LANXESS Corporation - January 15, 2016

Emerald Kalama Chemicals LLC in Kalama, WA, was cited for significant deficiencies during an FDA inspection. The inspection revealed issues with the quality unit's oversight of computer systems and data integrity, inadequate qualification of raw material suppliers, and deficient written procedures for handling product complaints. These observations indicate a need for improved quality control and compliance with good manufacturing practices.