FDA 483 - 3D Medical Manufacturing, Inc. - May 10, 2019
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Tec-Met, Inc. in Pennsauken, NJ, a contract manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures in finished device acceptance, in-process product control (specifically passivation), and inadequate corrective and preventive action procedures. Additionally, the firm failed to properly identify accepted incoming raw materials and ensure routine calibration of measuring equipment, indicating systemic issues in their quality management.
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