Varex Imaging Corporation – FDA 483, Mar 31, 2023

During an FDA inspection conducted from March 13 to March 31, 2023, Fresenius Kabi USA, LLC, a manufacturer of sterile injectable drug products in Grand Island, NY, received several observations on a Form 483. The inspection revealed significant concerns regarding the firm's adherence to Current Good Manufacturing Practices, with all five observations being repeats from a previous inspection. Key issues included deficiencies in procedures designed to prevent microbiological contamination. Inspectors observed operators engaging in poor aseptic techniques, such as exposed skin over open vials, touching non-sterile surfaces without sanitization, and improper hair covering during critical aseptic set-up activities. The facility's cleaning and disinfection systems were found inadequate, evidenced by undocumented residues on surfaces in aseptic support areas. Additionally, personnel gowning issues were noted, specifically an operator with fogged goggles obscuring vision while performing aseptic tasks. The inspection also highlighted an inadequate investigation into an Out-of-Specification result for endotoxin in Water for Injection, failing to determine a root cause or assess the impact on affected drug product batches. Furthermore, the aseptic process simulation program was deemed deficient as it did not ensure all qualified aseptic operators participated in annual re-qualifications. These observations require Fresenius Kabi to implement robust corrective and preventive actions to ensure the quality and sterility of its drug products.