FDA 483 - Aptuit (Oxford) Ltd. - July 22, 2016

Aptuit Oxford Ltd., a non-sterile API manufacturer in Oxfordshire, UK, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate water system maintenance leading to microbial contamination, an insufficient environmental monitoring program, and failures in laboratory controls and data integrity practices. The firm also demonstrated a pattern of inadequate OOS investigations and non-compliance with its own SOPs for sample management and stability sampling.