FDA 483 - True Diagnostics, Inc - December 29, 2025
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True Diagnostics, Inc. in Carlsbad, CA, received a Form 483 with three observations during an FDA inspection from December 22-29, 2025. The firm was cited for inadequate finished device acceptance procedures related to Unique Device Identification (UDI) labeling, systematic failures in verifying the effectiveness of corrective and preventive actions (CAPA), and insufficient validation of production equipment during a manufacturing site transfer. These deficiencies indicate significant quality system issues that led to regulatory non-compliance and production disruptions.
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