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FDA Inspection
•NEW LIFE DIAGNOSTICS LLC•April 2, 2026

NEW LIFE DIAGNOSTICS LLC – FDA Inspection, Apr 2, 2026

Record Details

This FDA Inspection record concerns NEW LIFE DIAGNOSTICS LLC, with an inspection on April 2, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.

Company
NEW LIFE DIAGNOSTICS LLC
Inspection Date
April 2, 2026
Product Type
Medical Devices & Rad Health
Office
Los Angeles District Office
Person
  • Jenny L. Chisem (Issuing Officer)
View Company Profile

ID · a4ca4a87-25a7-4ee7-81e1-807d5d5a9603

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1310622
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. ISO 13485:2016 Clause 7.5.8No documented system to assign unique device identification (UDI)
  2. ISO 13485:2016 Clause 8.5.3Preventive action not determined

Full citation text and observation details available on the Dashboard.

Other FDA inspections of NEW LIFE DIAGNOSTICS LLC

2
DateClassificationOfficeProject area
November 21, 2022NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
February 27, 2019VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for NEW LIFE DIAGNOSTICS LLC
  • FDA Inspection 1191670 - 2022-11-21
  • FDA Inspection 1081226 - 2019-02-27

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