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

Source: https://www.keypedia.com/records/483/protherics-uk-limited/576894ca-c378-4b9c-a8c5-d60c0679ec3a

> 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: Foreign - CBER (Bioresearch Monitoring)
- Summary: An FDA inspection of Protherics UK Ltd. in Llandysul, UK, revealed significant deficiencies in quality control testing procedures, facility qualification for aseptic operations, and environmental monitoring systems. These issues indicate potential risks to product quality and sterility assurance. The firm needs to address these systemic problems to ensure compliance with regulatory standards.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e