# FDA 483 - NEW LIFE DIAGNOSTICS LLC - February 27, 2019

Source: https://www.globalkeysolutions.net/records/483/new-life-diagnostics-llc/224c8ff8-bb6d-4f89-8bcb-e988495a744b

> FDA 483 for NEW LIFE DIAGNOSTICS LLC on February 27, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEW LIFE DIAGNOSTICS LLC
- Inspection Date: 2019-02-27
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: NEW LIFE DIAGNOSTICS LLC, a medical device manufacturer in Carlsbad, CA, was inspected from February 25-27, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process controls, equipment calibration, acceptance activity documentation, purchasing controls, and complaint handling procedures. These issues indicate a broad lack of established and followed quality system procedures.

## Related Officers

- [Consumer Safety Officer/Investigator at FDA](https://www.globalkeysolutions.net/people/marcia-g-evans/2e20a31d-0267-4040-b1a1-c0bec23b964b)
- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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

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