# FDA 483 - Autolus Limited - Unknown Date

Source: https://www.keypedia.com/records/483/autolus-limited/d733f917-4ba8-442c-b520-200b3a56c95e

> FDA 483 for Autolus Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Autolus Limited
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Autolus Limited (The Nucleus) in Stevenage, United Kingdom, a drug substance and drug product manufacturer, revealed significant deficiencies. Observations included incomplete validation of critical manufacturing processes and equipment, inadequate validation and monitoring of critical utilities, and insufficient disinfectant studies to prevent cross-contamination. These issues indicate a lack of assurance in product quality and control.

## Related Officers

- [investigator](https://www.keypedia.com/people/kathleen-r-jones/3760ffcd-ce90-4b7c-b0a6-726edc8264d8)
- [Kula N. Jha](https://www.keypedia.com/people/kula-n-jha/59961b64-fc92-440d-ae53-0bb03cbc9c78)
- [Jessica Chery](https://www.keypedia.com/people/jessica-chery/a7031c2d-307b-45b0-9078-0ce3f81dfc8a)
- [Andrew E. Timmons](https://www.keypedia.com/people/andrew-e-timmons/ef3d80e0-d372-43c5-b14b-98cb4f5c4b0b)

Company: https://www.keypedia.com/companies/autolus-limited/1961ca64-40e0-44c3-a789-bc25ce1244c2

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