483
EMSIEMSI – FDA 483, Dec 8, 2022
Record Details
EMSI, a Spec Developer in Tampa, FL, was inspected by the FDA from December 5-8, 2022. The inspection revealed deficiencies in the firm's quality system, specifically regarding finished device acceptance procedures and employee training. These issues indicate a lack of adherence to established protocols for device manufacturing and personnel competency.
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ID · 8e0dac7f-ce16-45fe-991b-c65db08509c4
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