483
Sterigenics US LLCSterigenics US LLC – FDA 483, May 31, 2023
Record Details
An FDA inspection of Sterigenics US LLC in Salem, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures, validate processes whose results cannot be fully verified, and maintain device history records in accordance with device master records. These issues indicate a lack of robust quality control over their manufacturing operations.
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ID · 2d9087ec-cdee-4cc2-bbae-ce5bd2f7f8ea
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