FDA 483 - Reading Scientific Services Ltd - June 16, 2025
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Reading Scientific Services Ltd, a control testing laboratory in Reading, United Kingdom, received an FDA Form 483 citing a significant failure to thoroughly review batch failures and instrument performance issues. The firm did not initiate or complete laboratory investigations for initial instrument performance failures observed during preliminary testing for multiple client batches. Additionally, their procedures lacked provisions for investigating equipment performance failures.
ID · e32f5ffb-eb6e-4e5d-a347-2c94197f7385