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

Source: https://www.keypedia.com/records/483/aptuit-oxford-ltd/8279583f-18f5-403e-be48-b461a44c0bbb

> FDA 483 for Aptuit (Oxford) Ltd. on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aptuit (Oxford) Ltd.
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2016-07-22](https://www.keypedia.com/records/483/aptuit-oxford-ltd/43d9aade-53c2-4262-8432-75e84019faf0)
- [483 - 2025-08-22](https://www.keypedia.com/records/483/aptuit-oxford-ltd/72b4bf3e-6b04-4678-922c-92130c9401e8)

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/aptuit-oxford-ltd/da0ef59c-f35f-478c-a844-0d223aa34b67

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8