# FDA 483 - Protherics UK Limited - June 23, 2022

Source: https://www.keypedia.com/records/483/protherics-uk-limited/5d0e85f0-c114-41b4-94b2-43e8a9dfbc75

> FDA 483 for Protherics UK Limited on June 23, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protherics UK Limited
- Inspection Date: 2022-06-23
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Protherics UK Ltd., a manufacturer in Llandysul, Ceredigion, UK, was inspected by the FDA. The inspection revealed significant deficiencies in quality control testing procedures, including issues with endotoxin analysis, media comparison, and drug sample analysis. Additionally, the facility's qualification for (b)(4) testing and its environmental monitoring system for classified areas were found to be deficient.

## Related Documents

- [483 - 2024-08-13](https://www.keypedia.com/records/483/protherics-uk-limited/59fd19f6-b8c6-4b49-b291-59e469dd4528)

## Related Officers

- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/protherics-uk-limited/ad10cdb3-3b0a-464d-bc88-0dee94941d89

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321