Protherics UK LimitedJune 23, 2022

FDA 483 - Protherics UK Limited - June 23, 2022

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Record Details

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.

Company: Protherics UK Limited
Inspection Date: June 23, 2022
Product Type: Biologics
Office: International Compliance Team
People: Burnell M. Henry (Investigator)
Eileen A. Liu

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ID · 5d0e85f0-c114-41b4-94b2-43e8a9dfbc75