FDA 483 - BioConnection B.V. - June 01, 2018

An FDA inspection of Bio Connection B.V. in Oss, Netherlands, revealed significant deficiencies in quality control and manufacturing processes. The firm was cited for inadequate validation of bioburden testing, failure to reject non-conforming components, and insufficient growth promotion studies. Additionally, the inspection found unreported manufacturing changes and the distribution of an unapproved product to the U.S. market, indicating a moderate level of non-compliance.