FDA EIR - PCAS - October 21, 2016

An FDA inspection of VLG Chem, a non-sterile intermediate and active pharmaceutical ingredients (APIs) manufacturer located in Villeneuve La Garenne, France, was conducted from October 17-21, 2016. This comprehensive Current Good Manufacturing Practice (CGMP) surveillance inspection was performed according to Compliance Program 7356.002F for Bulk Pharmaceutical Chemicals and ICH Q7 Good Manufacturing Practice Guidance for APIs. The inspection covered quality, facility and equipment, materials, production, packaging and labeling, and laboratory control systems. Notably, no FDA-483 Inspectional Observations were issued to VLG Chem during this inspection, indicating a generally compliant status. However, verbal discussions were held regarding specific areas for improvement. These included ensuring a traceable chain of custody for quality control samples from collection to laboratory receipt and evaluating the practice of sampling water from points of use with hose connections. Additionally, minor observations of missing initials on two batch records were noted but not cited as a formal violation due to their isolated nature. In response to the discussions, VLG Chem voluntarily updated their Standard Operating Procedure (SOP) for sample management to establish a clear chain of custody for QC samples. The company also committed to evaluating the risk associated with their water sampling practices. No other formal required actions were mandated by the FDA.