# FDA 483 - NEW LIFE DIAGNOSTICS LLC - April 02, 2026

Source: https://www.keypedia.com/records/483/new-life-diagnostics-llc/7b9972eb-086a-471d-b5cb-e27fdcea6ff3

> FDA 483 for NEW LIFE DIAGNOSTICS LLC on April 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEW LIFE DIAGNOSTICS LLC
- Inspection Date: 2026-04-02
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of NEW LIFE DIAGNOSTICS, Inc. in Carlsbad, CA, a manufacturer of parasitology ELISA test kits, revealed significant deficiencies in their quality system. The firm failed to adequately document a system for Unique Device Identification (UDI) and had not submitted required UDI data to the GUDID database for Class I devices. Additionally, the inspection found that the firm's corrective and preventive action (CAPA) procedures were inadequate, with numerous instances of nonconformances and recurring issues not leading to CAPA initiation or effective resolution.

## Related Documents

- [483 - 2019-02-27](https://www.keypedia.com/records/483/new-life-diagnostics-llc/224c8ff8-bb6d-4f89-8bcb-e988495a744b)

## Related Officers

- [Jenny L. Chisem](https://www.keypedia.com/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.keypedia.com/companies/new-life-diagnostics-llc/f3b5173f-4260-4a78-b021-40d1e0912a3f

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b