483
Hensler Surgical Products, LLCFDA 483 - Hensler Surgical Products, LLC - December 11, 2025
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Record Details
Hensler Surgical Products, LLC in Wilmington, NC, was inspected and received a Form FDA 483 with two observations. The inspection revealed significant deficiencies in personnel training and the firm's quality audit system. These issues indicate a lack of adherence to quality system requirements, potentially impacting product quality and regulatory compliance.
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