483
Nalge Nunc International CorporationNalge Nunc International Corporation – FDA 483, Jan 5, 2024
Record Details
Nalge Nunc International Corporation, a medical device manufacturer in Rochester, NY, received a Form FDA 483 with two observations. The inspection revealed deficiencies in the validation of software used for automated injection molding and inadequate establishment of equipment maintenance schedules for production machinery. These issues indicate potential concerns with quality system controls for manufacturing medical devices.
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ID · 75c9a95e-3d17-4b51-be1e-d8525b48d1da
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