FDA 483 - Lonza Walkersville, Inc. - February 06, 2017

Lonza Walkersville, Inc. received a Form 483 for significant deficiencies in its quality system for medical device production. The firm failed to adequately establish and maintain its organizational structure, provide necessary resources, ensure personnel training, and properly validate critical processes like cleaning and cleanroom qualifications. These systemic issues led to inadequate corrective actions, unaddressed sterility failures, and unupdated device listings.