FDA 483 - Product Safety Labs - July 24, 2025
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Product Safety Labs, a nonclinical laboratory in Dayton, NJ, was inspected and cited for two observations. The inspection revealed issues with the proper authorization of significant changes to standard operating procedures and the handling of archived materials, including finding wet tissues unattended in an unsecure laboratory. Additionally, the facility's design was found to be inadequate, with damaged contamination control floor mats and no maintenance procedure for them.
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ID · 9589cbe4-a409-4f6e-8eb5-502b99bf187f