FDA EIR - Lonza Tampa LLC - July 20, 2018

From July 16-20, 2018, the FDA conducted a routine Good Manufacturing Practice (GMP) and pre-approval inspection of Xcelience, LLC, a contract testing lab and human drug manufacturer in Tampa, Florida. This inspection was performed under the Drug Manufacturing Program and Pre-Approval Inspections/Investigations compliance programs, focusing on commercial manufacturing readiness, application conformance, and data integrity. The inspection resulted in one formal observation documented on a Form FDA 483. Xcelience was cited for failing to consistently document and justify deviations from established laboratory procedures and specifications. Specific instances included unrecorded temperature excursions in stability chambers in November 2016 and undocumented test injections during HPLC troubleshooting in January 2018. Additionally, two verbal observations were noted. Firstly, the electronic inventory system's "where-used" function for in-process materials was found to be inaccurate and not fully validated, leading to discrepancies between physical labels and software status. Secondly, process validation protocols incorporated heightened sampling but lacked corresponding heightened acceptance criteria, relying only on routine batch release specifications instead of statistical criteria. Xcelience management acknowledged the formal observation and committed to submitting a written response to the FDA within fifteen business days, detailing their corrective actions. The firm also indicated it would address the verbal observations to ensure full compliance.