# FDA 483 - TRUE DIAGNOSTICS, INC - March 09, 2022

Source: https://www.keypedia.com/records/483/true-diagnostics-inc/e64337b3-13c2-40dc-a782-48f153a4906e

> FDA 483 for TRUE DIAGNOSTICS, INC on March 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRUE DIAGNOSTICS, INC
- Inspection Date: 2022-03-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: TRUE DIAGNOSTICS, INC in Carlsbad, CA received a Form FDA-483 with six observations following an inspection from March 2-9, 2022. The firm was cited for significant deficiencies in its quality system, including a lack of process and equipment validation, inadequate environmental controls, and failures in establishing and maintaining critical procedures for in-process product, device history records, purchasing, and document control. These issues collectively indicate a broad breakdown in the firm's adherence to cGMP regulations for medical device manufacturing.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/true-diagnostics-inc/3752e6d9-846d-4f46-a70c-7e80cc5e8a39

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