FDA Inspection
Leesar IncLeesar Inc – FDA Inspection, Jul 18, 2025
Record Details
This FDA Inspection record concerns Leesar Inc, with an inspection on July 18, 2025, issued by the Florida District Office, covering medical devices & rad health.
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ID · 5002f213-fa78-46f3-aee1-c9a8f6892fce
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1276436
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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