FDA 483 - Aptuit (Oxford) Ltd. - August 22, 2025

Aptuit (Oxford) Ltd, an API and excipients manufacturer in Abingdon, United Kingdom, received a Form 483 with seven observations. The inspection revealed significant deficiencies in the firm's quality unit responsibilities, complaint investigations, microbiological contamination prevention, and contract laboratory oversight. These issues led to the release of products without adequate safety assurance and a lack of validated testing methods.