483
Acuity Surgical Devices, LLCAcuity Surgical Devices, LLC – FDA 483, Jan 27, 2025
Record Details
Acuity Surgical Devices, LLC, a medical device manufacturer in Irving, TX, was inspected by the FDA from January 21-27, 2025. The inspection revealed significant deficiencies in supplier management, including incomplete supplier evaluations and missing documentation. Additionally, the firm's employee training procedures were found to be inadequate, with issues in ensuring employee understanding of SOPs and addressing overdue trainings.
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ID · 3fc69532-35da-418d-b03e-971deabd0829
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