FDA 483 - BIOTECH EUROPE MEDITECH Inc. Ltd - April 14, 2022

BIOTECH EUROPE MEDITECH Inc. Ltd, a contract manufacturer in Roscommon, Ireland, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate documentation of corrective and preventive actions, unvalidated processes, uncontrolled production processes related to water system monitoring, and a lack of auditor independence in internal quality audits. These issues indicate a failure to ensure device conformity to specifications and proper quality management.