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

Source: https://www.globalkeysolutions.net/records/483/aptuit-oxford-ltd/43d9aade-53c2-4262-8432-75e84019faf0

> FDA 483 for Aptuit (Oxford) Ltd. on July 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aptuit (Oxford) Ltd.
- Inspection Date: 2016-07-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/deyaa-shaheen/ebbabce5-347c-4de4-abed-ba9da11c26ed)
- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd