FDA 483 - Symbiosis Pharmaceutical Services Limited - June 13, 2023

An FDA inspection of Symbiosis Pharmaceutical Services Limited, a sterile drug product manufacturer in Stirling, United Kingdom, revealed critical deficiencies in aseptic processing and quality control. Observations included inadequate validation of aseptic processes, poor management of GMP documents, and a deficient stability program. The firm also failed to maintain proper retention samples, ensure adequate cleaning and disinfection of aseptic areas, thoroughly investigate environmental monitoring excursions, and keep its manufacturing buildings in good repair.