FDA 483 - LONZA HAYWARD

An FDA inspection of Lonza Biologics Inc. in Hayward, CA, revealed significant deficiencies in their manufacturing and quality control processes. Key issues included a lack of standard operating procedures for cell bank homogeneity testing, inadequate accountability and investigation of working cell bank discrepancies, and poor identification of materials and equipment. Additionally, the firm's third-party materials warehouse exhibited multiple issues related to space, material storage, and labeling.