FDA Inspection
Tobra Medical IncTobra Medical Inc – FDA Inspection, Nov 19, 2025
Record Details
This FDA Inspection record concerns Tobra Medical Inc, with an inspection on November 19, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 0daa57ba-8432-4e7e-babe-6a65a1a59120
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1291992
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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