# FDA 483 - Cognita Labs LLC - December 13, 2023

Source: https://www.keypedia.com/records/483/cognita-labs-llc/a19a472e-3fbf-4df3-8279-48d33fbfc09a

> FDA 483 for Cognita Labs LLC on December 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cognita Labs LLC
- Inspection Date: 2023-12-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cognita Labs LLC, a medical device manufacturer in Santa Ana, CA, was inspected by the FDA from December 7-13, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the establishment of adequate procedures for device history records and the disposition of nonconforming products. These issues indicate a lack of proper documentation and control over manufacturing processes and product quality.

## Related Officers

- [Nancy Bogdanovic](https://www.keypedia.com/people/nancy-bogdanovic/acda7736-9cf7-46e0-ac7b-324fce8705bb)
- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/cognita-labs-llc/ea22378d-5ed1-424d-9fa5-dd71d700aaa5

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