FDA Inspection
Lucas Lifecare LLCLucas Lifecare LLC – FDA Inspection, May 13, 2026
Record Details
This FDA Inspection record concerns Lucas Lifecare LLC, with an inspection on May 13, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · ece4e79e-31d7-4e72-9aae-2b36be6f2a8c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1318004
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 7.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
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