483
Synergy Health Sterilisation M SDN BHDFDA 483 - Synergy Health Sterilisation M SDN BHD - November 23, 2023
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Record Details
An FDA inspection of Synergy Health Sterilisation M SDN BHD, a contract sterilizer in Kuala Ketil, Malaysia, revealed significant deficiencies in validation practices. The firm failed to adequately validate a sterilization process's operational qualification and could not provide validation for software used in production. These observations indicate a lack of robust quality system controls over critical manufacturing and software systems.
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ID · 39ec3b51-b4a7-4893-a86d-a7f70c20e5e1