Reading Scientific Services LtdJune 16, 2025

FDA 483 - Reading Scientific Services Ltd - June 16, 2025

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Record Details

An FDA inspection of Reading Scientific Services Ltd, a control testing laboratory in Reading, United Kingdom, revealed a significant failure in their quality control processes. The firm did not thoroughly investigate instrument performance failures during critical metal analysis, impacting multiple client batches. Additionally, their procedures lacked provisions for documenting and initiating investigations into such equipment performance issues.

Company: Reading Scientific Services Ltd
Inspection Date: June 16, 2025
Product Type: Drugs
Office: Division of Blood Components and Devices
People: Burnell M. Henry (Investigator)
Gene D. Arcy

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ID · 9776a18f-25cd-4338-b9c0-ed5fee9f453a