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

Source: https://www.keypedia.com/records/483/protherics-uk-limited/14850c9b-07c1-4419-b1c9-e62ac966898d

> 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: Division of Blood Components and Devices
- Summary: An FDA inspection of Protherics UK Limited, a biological drug substance manufacturer, revealed a significant issue with mold contamination. The firm failed to fully investigate the presence of various molds in a room holding manufacturing materials and stability samples, including inadequate environmental monitoring and a lack of assessment for similar HVAC units. This indicates a potential risk of cross-contamination and raises concerns about the firm's quality event management.

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## Related Officers

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917