# FDA 483 - Protherics UK Limited - August 13, 2024

Source: https://www.keypedia.com/records/483/protherics-uk-limited/59fd19f6-b8c6-4b49-b291-59e469dd4528

> FDA 483 for Protherics UK Limited on August 13, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protherics UK Limited
- Inspection Date: 2024-08-13
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Protherics UK Limited, a biological drug substance manufacturer in Llandysul, United Kingdom, was cited for failing to fully investigate and assess the impact of recurring mold contamination in a room used for manufacturing materials and stability samples. The firm's quality investigations and corrective actions were deemed insufficient, with inadequate environmental monitoring and a limited scope of investigation into the root cause. This indicates a significant lapse in quality control and contamination prevention practices.

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- [483 - 2022-06-23](https://www.keypedia.com/records/483/protherics-uk-limited/5d0e85f0-c114-41b4-94b2-43e8a9dfbc75)

## Related Officers

- [Feng Zhou](https://www.keypedia.com/people/feng-zhou/5cb267f1-2c3a-487c-b46d-ac1734d08bf9)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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