# FDA 483 - True Diagnostics, Inc - December 29, 2025

Source: https://www.keypedia.com/records/483/true-diagnostics-inc/a6c18c0e-c529-4ff3-bb9b-c8444ae89577

> FDA 483 for True Diagnostics, Inc on December 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: True Diagnostics, Inc
- Inspection Date: 2025-12-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)
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Company: https://www.keypedia.com/companies/true-diagnostics-inc/1f87d212-1e45-4a7e-95e6-e506f47d3c41

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6