FDA 483 - BioConnection B.V. - March 08, 2024

During an FDA inspection conducted from March 4-8, 2024, BioConnection, a pharmaceutical manufacturer located in Oss Noord-Brabant, The Netherlands, received a Form FDA 483. This document outlined two significant observations related to the firm's quality control systems for aseptic processing and environmental monitoring.The primary issue identified was inadequate microbial cross-contamination control within a sterile filling line. Inspectors observed that critical components and items, such as stopper bags, environmental monitoring plates, bottles, and equipment screens, were handled by both personnel engaged in aseptic operations and other operators. This lack of proper segregation and aseptic handling raises concerns about potential contamination risks to sterile products.A second critical observation related to the firm's environmental and personnel monitoring techniques. The FDA noted that procedures for finger dab plate sampling and surface contact plate sampling were not being followed correctly. Specifically, fingers were not rolled during sampling, and both finger and surface contact plates were in contact with the sampling medium for an insufficient duration (less than one second). Such improper technique can lead to inaccurate monitoring results, hindering the firm's ability to effectively assess and control microbial contamination in critical areas.BioConnection is required to address these inspectional observations by implementing robust corrective and preventive actions to ensure compliance with good manufacturing practices.