USpharma LtdMay 11, 2023

FDA 483 - USpharma Ltd - May 11, 2023

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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.

Company: USpharma Ltd
Inspection Date: May 11, 2023
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Ronald Ifraimov (investigator)

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ID · 5b85d918-4bc8-49f3-a559-00bb1568cc04