483
USpharma, Ltd., Co.USpharma, Ltd., Co. – FDA 483, May 11, 2023
Record Details
USpharma Ltd, a medical device manufacturer in Miami Lakes, FL, was inspected from May 10-11, 2023. The inspection revealed that the firm failed to submit Medical Device Reports (MDRs) within the required 30 days. This failure specifically pertained to two complaints where a marketed device may have malfunctioned and potentially caused patient injury.
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ID · 5b85d918-4bc8-49f3-a559-00bb1568cc04
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