483
Norman Noble IncNorman Noble Inc – FDA 483, Dec 19, 2024
Record Details
Norman Noble Inc, a medical device manufacturer in Highland Heights, OH, received two observations during an FDA inspection. The firm was cited for inadequate process validation, specifically concerning software used in final inspection, which was a repeat observation. Additionally, deficiencies were noted in their clean room environmental control procedures, with particulate testing failing to meet ISO Class 7 standards.
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ID · 66260570-93d2-40da-95c8-c1c2cb985d67
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