483
Aptuit (Oxford) Ltd.Aptuit (Oxford) Ltd. – FDA 483, Aug 22, 2025
Record Details
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.
View Company Profile
ID · 8279583f-18f5-403e-be48-b461a44c0bbb
Other documents for Aptuit (Oxford) Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.