FDA EIR - Bioreliance Ltd. - March 15, 2019

An FDA inspection of BioReliance Limited, a licensed bulk vaccine manufacturer and contract test laboratory in Glasgow, United Kingdom, occurred from March 7-15, 2019. Conducted under the FY 2019 Team Biologics Work Plan, guided by regulatory framework CP 7345.848 for Biological Drug Products, the inspection identified several critical deficiencies. Main violations included persistent failures in aseptic techniques during laboratory testing, leading to cross-contamination, and a consistent lack of timely and effective implementation of corrective and preventive actions for recurring deviations. The company also failed to adhere to written sanitation procedures for cleaning and maintaining equipment in both manufacturing and laboratory testing environments. Additionally, disinfectant effectiveness studies were deemed inadequate, with gaps in demonstrating efficacy across all relevant surfaces and meeting acceptance criteria. The inspection also noted deficiencies in investigation records, which often lacked complete conclusions and follow-up, and issues with batch production documentation and cleanroom media simulation studies. At the inspection's conclusion, an FDA-483, detailing these observations, was issued to David McClelland, Head of EU Biologics Operations. BioReliance Limited confirmed its commitment to conduct thorough investigations and implement necessary corrective actions in response to these findings within 15 working days.