FDA EIR - Xellia Pharmaceuticals USA LLC - January 31, 2020

An FDA Pre-Approval Inspection and surveillance Good Manufacturing Practice (GMP) inspection was conducted at Xellia Pharmaceuticals USA LLC from January 27 to January 31, 2020. This inspection, which also covered an Abbreviated New Drug Application (ANDA) for Vancomycin HCl for Injection, USP 10g/vial, identified significant quality control issues. The primary violations, documented in a two-item FDA 483, included the failure to replace filters after failed integrity testing according to written procedures, and deficiencies in the 100% visual inspection process, leading to a failure to identify finished product defects. Furthermore, the firm lacked scientific data to demonstrate that its lyophilization process did not negatively impact the finished product. Additional concerns discussed verbally included particulate issues with stoppers, low process validation batch yields, unapproved manual corrections on in-process labels, and an incorrect stage for bioburden monitoring of the bulk drug solution for U.S. market products. Recurring issues with filter integrity test failures, environmental monitoring excursions related to product spills, and personnel monitoring deviations were also noted. Xellia Pharmaceuticals USA LLC management stated they would submit a written response to the FDA 483 observations within 15 business days, with several corrective actions for environmental controls already in progress.