FDA 483 - Terumo BCT Ltd - February 07, 2020

Terumo BCT Ltd, a sterile parenteral manufacturer in Larne, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included failures in following procedures to prevent microbiological contamination, specifically regarding sterilization validation processes and disinfectant efficacy studies. Additionally, the firm's batch production and control records were found to be incomplete, lacking essential in-process bioburden test results and review instructions.