483
IonisosIonisos – FDA 483, Sep 12, 2024
Record Details
Ioniscs, a contract gamma sterilizer in Pouzauges, France, received four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for change control, software validation, deviation management, and corrective and preventive actions. These issues led to the implementation of unvalidated software and non-compliant product treatments.
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ID · fd5f263b-cf97-4a1f-89ca-21573c554708
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