# FDA 483 - Oxford Biomedica (UK) Limited - February 11, 2019

Source: https://www.globalkeysolutions.net/records/483/oxford-biomedica-uk-limited/31fbf010-01f2-4ebe-bd52-4a62b2ed2b01

> FDA 483 for Oxford Biomedica (UK) Limited on February 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxford Biomedica (UK) Limited
- Inspection Date: 2019-02-11
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Oxford Biomedica Ltd. in Oxford, UK, was cited for significant deficiencies in its quality system related to deviation management and investigations. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, lacking complete root cause analyses and timely corrective actions. Additionally, deviation forms did not consistently include opening dates, hindering the assessment of timely closure for various deviation types.

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.globalkeysolutions.net/companies/oxford-biomedica-uk-limited/12d29c20-d7d1-4ab9-830f-5d9f25a506ad

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