FDA Inspection
Encore LaboratoryEncore Laboratory – FDA Inspection, Jan 9, 2026
Record Details
This FDA Inspection record concerns Encore Laboratory, with an inspection on January 9, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 23a3cff2-5ac1-4e6a-8d24-006bac2bb592
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1298062
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.90(a)Nonconforming product control
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