FDA EIR - Xellia Pharmaceuticals USA LLC - October 13, 2016

An FDA compliance inspection was conducted at Xellia Pharmaceuticals USA LLC in Bedford, OH, from October 11-13, 2016. This follow-up inspection, performed under a modified consent decree stemming from a previous injunction against Ben Venue Laboratories (the facility's former occupant), focused on Xellia's labeling and secondary packaging operations for Vancomycin HCl for Injection, USP. The inspection did not result in an FDA-483, indicating no formal observations of objectionable conditions. However, two key discussion points were raised with company management. First, during the Operational Qualification (OQ) of the packaging line, the firm initially deviated from the written protocol for physical vial label print verification, leading to an execution error. Xellia addressed this through a corrective action, re-executing the affected OQ sections. Second, concerns were noted regarding the Performance Qualification (PPQ) protocol for the Vision System, which appeared not to adequately test "worst-case" scenarios for detecting missing vials or errors in lot numbers, identification numbers, and expiration dates. Management was advised to justify the protocol and ensure it robustly challenges the system's ability to detect all potential defects. The FDA conveyed that the final determination regarding the facility's status would be made by their management and compliance officers, with Xellia management agreeing to address the raised discussion items.