FDA 483 - BSV BioScience GmbH - March 11, 2016

BSV BioScience GmbH, an API manufacturer in Baesweiler, Germany, was cited for significant deficiencies during an FDA inspection. The observations include inadequate controls for computerized systems leading to potential data deletion and lack of backups, failure to implement formal change controls for production shutdowns, improper documentation and investigation of customer complaints, and insufficient investigation and corrective actions for out-of-specification water test results. These issues indicate systemic problems with data integrity, quality management, and adherence to established procedures.