483
SensiMedical LLCSensiMedical LLC – FDA 483, Jan 19, 2024
Record Details
SensiMedical LLC, an initial importer in Miami, FL, was inspected regarding its Class II sterile medical devices. The inspection revealed a significant deficiency where the firm failed to establish a design history file and adequate design control procedures for its intravascular administration sets, despite continuing to distribute these devices. This indicates a serious lack of compliance with medical device regulations.
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ID · c92f9089-d704-408f-af8f-7038d6ffe0f0
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