483
Sterigenics U.S., LLCSterigenics U.S., LLC – FDA 483, Dec 17, 2024
Record Details
An FDA inspection of Sterigenics U.S., LLC in Schaumburg, IL, a medical device contract sterilization facility, revealed inadequacies in their corrective and preventive action (CAPA) procedures. The firm failed to perform retrospective reviews of nonconformances related to specific CAPAs, indicating a deficiency in their quality system. This suggests a moderate severity issue concerning the effectiveness of their CAPA process.
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ID · 3a352343-ca21-4acb-bc9b-cb2cb4607f9c
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