FDA 483 - BSV Bioscience Gmbh - January 25, 2019

An FDA inspection of BSV BioScience GmbH in Baesweiler, Germany, an API manufacturer, identified three significant observations. The firm lacked written procedures for repeating API production steps and reprocessing batches, failed to establish appropriate time limits for production phases leading to exceeded validated hold times, and did not have written procedures for verifying correct labels and labeling for finished API units. These findings indicate deficiencies in the firm's manufacturing controls and documentation practices.